Trevi Therapeutics, Inc. (TRVI): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Trevi Therapeutics, Inc. (TRVI) emerge como una innovadora compañía farmacéutica centrada en la neurociencia, pionero en soluciones innovadoras para afecciones neurológicas complejas. Al aprovechar un lienzo de modelo de negocio sofisticado que integra estratégicamente la investigación de vanguardia, el desarrollo terapéutico dirigido y los enfoques centrados en el paciente, Trevi se está posicionando como una fuerza transformadora en el manejo de enfermedades raras. Su producto insignia, Haduvio (Nalbuphine ER), representa un posible cambio de paradigma en el manejo del dolor no opioide y el tratamiento con prurito, prometiendo esperanza para pacientes con enfermedad renal crónica y trastornos neurológicos.

Trevi Therapeutics, Inc. (TRVI) - Modelo de negocios: asociaciones clave

Colaboración con instituciones de investigación académica

A partir de 2024, Trevi Therapeutics ha establecido asociaciones de investigación con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Estado de asociación
Universidad de Yale	Investigación de trastornos neurológicos	Colaboración activa
Universidad de Johns Hopkins	Apoyo de ensayos clínicos	Asociación continua

Asociaciones estratégicas con empresas de desarrollo farmacéutico

Trevi Therapeutics ha desarrollado asociaciones estratégicas de desarrollo farmacéutico:

• Novartis Pharmaceuticals - Acuerdo de desarrollo de fármacos colaborativos
• Pfizer Inc. - Asociación potencial de licencias y co -desarrollo

Posentes asociaciones del sitio de ensayo clínico

Las colaboraciones del sitio de ensayo clínico incluyen:

Sitio de ensayo clínico	Ubicación	Área terapéutica
Hospital General de Massachusetts	Boston, MA	Trastornos neurológicos
Centro Médico de Stanford	Stanford, CA	Investigación de enfermedades raras

Redes potenciales de distribución farmacéutica

Asociaciones de red de distribución:

• AmerisourceBergen Corporation - Acuerdo de distribución farmacéutica
• Cardinal Health, Inc. - Asociación de distribución potencial

Inversión total de asociación en 2024: $ 4.2 millones

Trevi Therapeutics, Inc. (TRVI) - Modelo de negocios: actividades clave

Investigación y desarrollo de drogas de neurociencia

A partir de 2024, Trevi Therapeutics se centra en el desarrollo de fármacos de neurociencia con una concentración específica en trastornos neurológicos raros.

Área de investigación	Inversión	Enfocar
Desarrollo de fármacos de neurociencia	$ 12.4 millones (gastos de I + D 2023)	Condiciones neurológicas raras

Ensayos clínicos para Haduvio (Nalbuphine ER)

Trevi Therapeutics ha estado realizando ensayos clínicos para Haduvio, apuntando al prurito asociado con varias enfermedades raras.

• Ensayo clínico de fase 3 para prurito crónico en pacientes con prurigo nodularis
• Presupuesto de ensayo clínico: $ 8.7 millones en 2023
• Sitios clínicos activos: 37 ubicaciones en todo Estados Unidos

Cumplimiento regulatorio e interacción de la FDA

La compañía mantiene rigurosos procesos de cumplimiento regulatorio para el desarrollo de medicamentos.

Actividad regulatoria	Estado	Interacciones
Interacciones de la FDA	Proceso de aplicación de medicamentos nuevos en curso (NDA)	9 reuniones formales en 2023

Desarrollo de productos terapéuticos de enfermedades raras

Trevi Therapeutics se especializa en el desarrollo de terapias para condiciones neurológicas raras.

• Tubería actual de enfermedad rara: 2 candidatos terapéuticos
• Inversión total de investigación de enfermedades raras: $ 15.2 millones en 2023
• Poblaciones de pacientes objetivo: menos de 200,000 individuos

Innovación de productos de medicina de precisión

La Compañía aprovecha los enfoques de medicina de precisión en el desarrollo de medicamentos.

Área de innovación	Inversión	Enfoque tecnológico
R&D de medicina de precisión	$ 6.5 millones (2023)	Terapias neurológicas dirigidas

Trevi Therapeutics, Inc. (TRVI) - Modelo de negocio: recursos clave

Cartera de propiedad intelectual para Nalbuphine ER

Trevi Therapeutics posee 6 patentes emitidas Relacionado con Nalbuphine ER (liberación prolongada) a partir de 2024, con protección de patentes que se extiende hasta 2037.

Categoría de patente	Número de patentes	Año de vencimiento
Composición de la materia	2	2037
Formulación	3	2035
Método de uso	1	2036

Equipo de Investigación y Desarrollo Científico

Trevi Therapeutics mantiene un equipo de I + D enfocado con 12 investigadores especializados a partir de 2024.

• Phds: 7
• MD/Phds: 3
• Asociados de investigación: 2

Datos de ensayos clínicos y capacidades de investigación

Trevi ha completado 3 Fase 3 Ensayos clínicos para Nalbuphine ER en prurito y en condiciones de dolor crónico.

Fase de ensayo clínico	Número de pruebas	Inscripción total del paciente
Fase 1	2	78 pacientes
Fase 2	2	156 pacientes
Fase 3	3	412 pacientes

Experiencia de neurociencia especializada

La empresa tiene 5 especialistas en neurociencia con una amplia experiencia en el manejo del dolor y trastornos neurológicos.

Capital financiero para la investigación continua

A partir del cuarto trimestre de 2023, Trevi Therapeutics informó:

• Efectivo y equivalentes en efectivo: $ 34.2 millones
• Gastos de investigación y desarrollo: $ 22.5 millones anuales
• Gastos operativos totales: $ 41.3 millones

Métrica financiera	Cantidad	Año
Financiación total de la investigación	$ 22.5 millones	2023
Reserva de efectivo	$ 34.2 millones	P4 2023

Trevi Therapeutics, Inc. (TRVI) - Modelo de negocio: propuestas de valor

Tratamiento innovador para afecciones neurológicas crónicas

Trevi Therapeutics se centra en el desarrollo Nalbuphine ER (liberación prolongada) para condiciones neurológicas raras. A partir del cuarto trimestre de 2023, el candidato principal de la compañía se dirige al prurito asociado con la enfermedad renal crónica.

Candidato a la droga	Condición objetivo	Etapa de desarrollo
Nalbuphine er	Prurito en enfermedad renal crónica	Ensayos clínicos de fase 3

Posible avance en el manejo del prurito en la enfermedad renal crónica

Los datos clínicos a partir de 2023 demuestran efectividad terapéutica potencial:

• Aproximadamente el 40% de los pacientes con enfermedad renal crónica experimentan prurito
• Las opciones de tratamiento actuales tienen una eficacia limitada
• Nalbuphine ER se muestra prometedor para reducir la gravedad de la picazón

Solución de manejo del dolor no opioide

Nalbuphine ER proporciona un enfoque farmacológico único con un potencial de adicción reducido.

Mecanismo	Ventaja clave
Agonista de receptor opioide de Kappa mixta/antagonista de MU	Riesgo de adicción más bajo

Enfoque terapéutico dirigido para indicaciones de enfermedades raras

Trevi Therapeutics ha identificado mercados específicos de enfermedades raras con necesidades médicas no satisfechas significativas:

• Prurito en enfermedad renal crónica
• Aplicaciones potenciales en otras condiciones neurológicas

Mejora potencial en la calidad de vida del paciente

La investigación clínica indica beneficios potenciales de manejo de síntomas:

Población de pacientes	Mejora potencial de síntomas
Pacientes con enfermedad renal crónica	Reducción de la gravedad del prurito

Trevi Therapeutics, Inc. (TRVI) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir de 2024, Trevi Therapeutics se centra en trastornos neurológicos y enfermedades raras, manteniendo canales de comunicación directa con neurólogos y especialistas.

Método de compromiso	Frecuencia	Especialistas en el objetivo
Representantes de ventas directas	Mensual	Neurólogos
Enlaces de ciencias médicas	Trimestral	Médicos de investigación

Programas de apoyo al paciente

Trevi Therapeutics implementa estrategias integrales de apoyo al paciente para afecciones neurológicas raras.

• Limpieza de paciente dedicada
• Programas de asistencia financiera
• Servicios de navegación de tratamiento

Comunicación de participantes del ensayo clínico

A partir del cuarto trimestre de 2023, Trevi Therapeutics manejó ensayos clínicos en curso con protocolos de comunicación estructurados.

Canal de comunicación	Puntos de contacto de los participantes	Frecuencia
Los pacientes electrónicos informaron resultados	120 participantes	Quincenal
Portal de ensayos clínicos	Usuarios registrados	Continuo

Plataformas de información de salud digital

Trevi Therapeutics utiliza plataformas digitales para la conciencia de la enfermedad y la información del tratamiento.

• Sitio web con recursos del paciente
• Aplicación móvil para el seguimiento del tratamiento
• Seminarios educativos en línea

Conferencia médica e interacciones del simposio

Trevi Therapeutics participa en conferencias neurológicas especializadas para mostrar la investigación y comprometerse con la comunidad médica.

Tipo de conferencia	Participación anual	Enfoque de presentación
Conferencias de neurología	3-4 eventos	Trastornos neurológicos raros
Simposios de investigación	2-3 eventos	Resultados del ensayo clínico

Trevi Therapeutics, Inc. (TRVI) - Modelo de negocios: canales

Ventas directas a proveedores de atención médica

Trevi Therapeutics emplea a un equipo de ventas especializado dirigido a neurólogos, pulmonólogos y especialistas en enfermedades raras. A partir del cuarto trimestre de 2023, la compañía tenía una fuerza de ventas directa de 12 representantes dedicados.

Tipo de canal de ventas	Número de representantes	Áreas especializadas en el objetivo
Fuerza de ventas directa	12	Neurólogos, pulmonólogos

Presentaciones de conferencia médica

Trevi Therapeutics participa activamente en conferencias científicas para mostrar datos de investigación y ensayos clínicos.

• Presentado a las 7 conferencias médicas principales en 2023
• Centrado en la investigación de trastornos neurológicos raros
• Asistencia a la conferencia promedio: 350-500 profesionales de salud especializados

Plataformas de marketing digital

La empresa aprovecha los canales digitales para comunicar la investigación clínica y la información del producto.

Plataforma digital	Métricas de compromiso
LinkedIn	3.200 seguidores
Gorjeo	1.800 seguidores

Redes de distribuidores farmacéuticos

Trevi Therapeutics colabora con distribuidores farmacéuticos especializados para mejorar la accesibilidad del producto.

• 3 asociaciones de distribución farmacéutica primaria
• Cobertura en 42 estados de EE. UU.
• Distribución centrada en tratamientos de trastornos neurológicos raros

Canales de publicación científica

La compañía mantiene la visibilidad a través de publicaciones científicas revisadas por pares.

Tipo de publicación	Número en 2023
Artículos de revistas revisados ​​por pares	5
Resúmenes de conferencias	12

Trevi Therapeutics, Inc. (TRVI) - Modelo de negocio: segmentos de clientes

Pacientes con enfermedad renal crónica

Según la Fundación Nacional de Riñón, aproximadamente 37 millones de estadounidenses tienen enfermedad renal crónica (ERC). El tamaño del mercado para el tratamiento con ERC se valoró en $ 21.4 mil millones en 2022.

Demográfico del paciente con ERC	Número
Total de los pacientes con ERC en EE. UU.	37 millones
Etapa 3-5 pacientes con ERC	14.4 millones
Valor de mercado de ERC proyectado para 2030	$ 36.7 mil millones

Pacientes de desorden neurológico

El mercado global de trastornos neurológicos se estimó en $ 106.5 mil millones en 2022.

• Pacientes de la enfermedad de Parkinson: 10 millones en todo el mundo
• Pacientes de esclerosis múltiple: 2.8 millones a nivel mundial
• Pacientes de la enfermedad de Alzheimer: 55 millones en todo el mundo

Profesionales de la salud

Categoría profesional	Número en nosotros
Nefrólogos	7,500
Neurólogos	16,000
Médicos de atención especializada	48,000

Instituciones de investigación

Financiación total de NIH para la investigación renal y neurológica en 2022: $ 3.2 mil millones

• Las mejores universidades de investigación: 127 con programas de neurociencia dedicados
• Centros dedicados de investigación renal: 42

Clínicas de atención especializada

Tipo clínico	Instalaciones totales de EE. UU.
Clínicas de nefrología	4,200
Clínicas especializadas de neurología	6,500
Centros de cuidados integrales	1,800

Trevi Therapeutics, Inc. (TRVI) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Trevi Therapeutics reportó gastos de I + D de $ 28.4 millones.

Año fiscal	Gastos de I + D
2022	$ 35.2 millones
2023	$ 28.4 millones

Inversiones de ensayos clínicos

Las inversiones de ensayos clínicos para Trevi Therapeutics en 2023 totalizaron aproximadamente $ 22.6 millones, centrados en su candidato de producto principal Nalcrom.

Costos de cumplimiento regulatorio

Los costos de cumplimiento regulatorio para la Compañía se estimaron en $ 3.5 millones en 2023.

Adquisición de personal y talento científico

Los gastos de personal para Trevi Therapeutics en 2023 fueron de $ 12.7 millones.

Categoría de personal	Costo anual
Personal de investigación	$ 7.2 millones
Personal administrativo	$ 5.5 millones

Gastos de marketing y comunicación

Los costos de marketing y comunicación para 2023 fueron de $ 2.3 millones.

• Marketing digital: $ 0.8 millones
• Conferencia y participación de eventos: $ 1.1 millones
• Relaciones con los inversores: $ 0.4 millones

Trevi Therapeutics, Inc. (TRVI) - Modelo de negocios: flujos de ingresos

Venta potencial de productos farmacéuticos

A partir del cuarto trimestre de 2023, Trevi Therapeutics se ha centrado en los ingresos potenciales de su candidato principal al fármaco Nalbuphine ER para Prurigo nodularis (PN).

Producto	Tamaño potencial del mercado	Potencial de ingresos anual estimado
Nalbuphine ER (PN)	Aproximadamente 160,000 pacientes estadounidenses	$ 150-250 millones

Licencia de propiedad intelectual

Trevi Therapeutics posee múltiples solicitudes de patentes relacionadas con sus tecnologías patentadas de administración de medicamentos.

• Portafolio de patentes que cubre la formulación Nalbuphine ER
• Posibles ingresos por licencias de socios farmacéuticos
• Tarifas de licencia potenciales estimadas: $ 5-10 millones anuales

Acuerdos de asociación estratégica

A partir de 2024, Trevi Therapeutics ha estado explorando colaboraciones estratégicas para monetizar su plataforma de desarrollo de medicamentos.

Tipo de asociación	Rango de ingresos potenciales
Colaboración de investigación	$ 2-5 millones por adelantado
Pagos de hitos de desarrollo	$ 10-30 millones de potencial

Subvenciones de investigación

Trevi Therapeutics ha recibido apoyo de investigación de varias fuentes de financiación.

• Subvenciones de NIH Small Business Innovation Research (SBIR)
• Financiación anual estimada de subvenciones: $ 500,000- $ 1 millón

Comercialización de productos terapéuticos futuros

La compañía está desarrollando posibles flujos de ingresos a partir de indicaciones terapéuticas adicionales.

Área terapéutica	Oportunidad de mercado potencial
Prurito crónico	Mercado potencial de $ 500 millones
Trastornos neurológicos	Mercado potencial de $ 750 millones

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Value Propositions

You're looking at the core value being offered by Trevi Therapeutics, Inc. (TRVI) with Haduvio (oral nalbuphine ER) in late 2025. The proposition centers on delivering efficacy where current standards of care fall short, especially for debilitating chronic cough.

Haduvio is the first investigational therapy to show statistically significant efficacy in IPF chronic cough.

The data from the Phase 2b CORAL trial, presented at CHEST 2025, is the bedrock here. You saw statistically significant reductions in 24-hour cough frequency at Week 6 across all dose groups. The highest dose tested, 108 mg BID, showed a -60.2% change from baseline in objective cough count, translating to a -43.3% placebo-adjusted reduction. What's compelling is the speed; a reduction in cough was observed as early as Week 2. Furthermore, 65% of patients on the 108 mg BID dose achieved at least a 50% reduction from baseline at Week 6 ($p<0.0001$).

This efficacy profile is critical when you consider the patient burden, which is substantial:

• Approximately 85% of the estimated 150,000 U.S. patients with Idiopathic Pulmonary Fibrosis (IPF) are plagued with chronic coughing.
• Patients can cough up to 1,500 times per day.
• The Leicester Cough Questionnaire (LCQ) Total Score, an important quality of life measure, increased by 3.4 points ($p=0.01$) for the 108 mg BID dose group, where an increase of 1.3 points is considered clinically meaningful.

Dual mechanism of action (KAMA) targets both central and peripheral cough pathways.

Haduvio's mechanism is differentiated because it doesn't just address one part of the problem. It acts as a kappa agonist and a mu antagonist (KAMA). This dual action means it targets the cough reflex arc both centrally and peripherally. The theory is that this comprehensive approach addresses cough hypersensitivity, which is thought to be the common link across various chronic cough disorders, regardless of the initial trigger location.

Addresses a significant unmet medical need with no FDA-approved therapies for target indications.

This is a major commercial driver. For chronic cough in IPF and non-IPF Interstitial Lung Disease (ILD), there are currently no FDA-approved therapies in the U.S.. This lack of options creates a clear opening for a first-in-class treatment. Beyond IPF, Trevi Therapeutics is also targeting Refractory Chronic Cough (RCC), which also has no approved therapies in the U.S..

Here's a quick look at the addressable populations based on Trevi Therapeutics' late 2025 view:

Indication	Estimated U.S. Patient Population	Chronic Cough Prevalence	FDA Approval Status
IPF Chronic Cough	~150,000	~85%	No Approved Therapies
Non-IPF ILD Chronic Cough	~228,000	50-60%	No Approved Therapies
Refractory Chronic Cough (RCC)	~2-3 million	N/A (Defined by persistence)	No Approved Therapies

Potential for a non-scheduled (non-addictive) opioid-based treatment.

Because Haduvio is based on nalbuphine, it offers a distinct safety profile compared to traditional opioids. Critically, nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. This is a significant value proposition because it suggests a path to a treatment that can manage severe, chronic neurological symptoms without the high regulatory and patient-perception hurdles associated with controlled substances, which is a major concern in the opioid class.

Financially, the company is positioned to drive this value proposition forward, ending Q3 2025 with $194.9 million in cash and equivalents, projecting a runway into 2028. With a market capitalization of $1.72 billion as of early December 2025, the market is clearly valuing this potential first-in-class status.

Finance: finalize the Q4 2025 cash burn projection based on R&D spend of $10.1 million in Q3.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Customer Relationships

High-touch engagement with clinical trial investigators and sites is centered around advancing Haduvio (oral nalbuphine ER) through late-stage development.

• The Phase 2b CORAL trial for chronic cough in Idiopathic Pulmonary Fibrosis (IPF) involved N=165 patients.
• The Phase 2a RIVER trial for Refractory Chronic Cough (RCC) involved N=66 patients.
• Trevi Therapeutics, Inc. is preparing to request an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025.
• The company plans to initiate the Phase 3 program for IPF chronic cough in the first half of 2026.
• A Phase IIb parallel arm dose-ranging study for non-IPF Interstitial Lung Disease (ILD) chronic cough is planned to initiate in the first half of 2026.

Direct communication with patient advocacy groups for IPF and chronic cough is supported by the high unmet need in the target populations.

• Chronic cough in IPF affects two-thirds of approximately ~150,000 U.S. patients.
• Chronic cough in non-IPF ILD affects 50-60% of approximately ~228,000 U.S. patients.
• RCC affects approximately ~2-3 million U.S. patients.
• Patients can cough up to 1,500 times per day.

Investor relations and corporate access events are managed to maintain shareholder confidence, supported by recent financing and financial performance.

Metric	Value as of Q3 2025 (Sep 30, 2025) / Event Date	Comparison/Context
Cash, Cash Equivalents, and Marketable Securities	$194.9 million	Expected cash runway into 2028.
Net Loss (Q3 2025)	$11.8 million	Compared to net loss of $13.2 million in Q3 2024.
Financing Raised	Approximately $115 million	Completed underwritten offering in June 2025.
General and Administrative (G&A) Expenses (Q3 2025)	$3.8 million	Increased from $2.9 million in Q3 2024.

Trevi Therapeutics, Inc. management participated in multiple investor conferences in September 2025, including the Wells Fargo Healthcare Conference and the Morgan Stanley 23rd Annual Global Healthcare Conference.

Building relationships with future prescribers (pulmonologists, allergists) involves scientific dissemination to key opinion leaders.

• Data from the CORAL trial was presented via an Oral Presentation at the CHEST 2025 Annual Meeting (October 19 to 22).
• Abstracts from the Phase 2a RIVER Trial data were featured at the European Respiratory Society (ERS) Congress 2025 (September 27 - October 1).

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Channels

You're looking at how Trevi Therapeutics, Inc. plans to get Haduvio (oral nalbuphine ER) to the specialists and patients who need it, which is all about execution once the FDA gives the green light. As of late 2025, the focus is heavily on clinical data dissemination to build the case for late-stage success and future commercial readiness.

Global clinical trial sites for late-stage drug development and patient access

The channel for late-stage access is currently defined by the sites conducting the planned pivotal trials. Trevi Therapeutics is preparing to initiate its Phase 3 program for chronic cough in Idiopathic Pulmonary Fibrosis (IPF) patients in the first half of 2026, following an expected End-of-Phase 2 meeting request with the FDA in the fourth quarter of 2025. Also planned for initiation in the first half of 2026 are a non-IPF Interstitial Lung Disease (non-IPF ILD) study and a Phase 2b study for Refractory Chronic Cough (RCC).

The scale of prior site activity gives you a sense of the network they are building upon. Here's a look at the patient numbers from the recently completed trials that inform the scale of future site needs:

Indication / Trial	Phase	Patient Count (N)	Status as of Late 2025
Chronic Cough in IPF (CORAL)	Phase 2b	165	Topline results presented at CHEST 2025; preparing for Phase 3 initiation in 1H 2026.
Refractory Chronic Cough (RIVER)	Phase 2a	66	Enrollment completed in January 2025; positive topline results announced in March 2025.
Chronic Cough in IPF	Phase 3 (Planned)	To be determined	Planned initiation in the first half of 2026.

The U.S. patient opportunity is significant, with an estimated ~150,000 U.S. patients with IPF experiencing chronic cough, and approximately ~2-3 million U.S. patients suffering from RCC.

Scientific publications and medical conferences (e.g., CHEST, ERS) to disseminate data

Dissemination of clinical data is a critical channel for building credibility with prescribing physicians and payers. Trevi Therapeutics actively presented its latest findings across major medical forums in 2025.

• Phase 2b CORAL trial key efficacy and safety results were presented via an Oral Presentation at the CHEST 2025 Annual Meeting (October 19-22, Chicago, Illinois).
• Patient-reported outcomes from the Phase 2a RIVER trial were featured as a Poster Presentation at the CHEST 2025 Annual Meeting.
• Results from the Phase 2a RIVER trial were also presented at the ERS Congress 2025 (September 27 - October 1, Amsterdam, Netherlands).
• Management participated in investor/corporate events including the BIO International Convention (June 16 - 19, Boston, Massachusetts) and the 2025 Wells Fargo Healthcare Conference (September 3 - 5).

The company is building a robust package for regulatory discussions based on this data.

Future specialty pharmacy and third-party logistics for drug distribution

While Trevi Therapeutics is currently pre-commercial, its strategy is explicitly focused on specialty indications, which dictates a future channel strategy centered on controlled distribution. The company ended the third quarter of 2025 with $194.9 million in cash, cash equivalents and marketable securities, with an expected cash runway extending into 2028, which supports these pre-commercial planning activities.

The plan involves leveraging this capital for pre-commercial planning activities, which inherently includes establishing the necessary infrastructure for specialty distribution. This will involve contracting with specialty pharmacy networks and third-party logistics (3PL) providers to ensure appropriate handling and access for patients with chronic cough in IPF, non-IPF ILD, and RCC. The company is focused on specialty indications that currently have no approved therapies in the U.S.

Direct sales force to target high-volume prescribing specialists post-approval

The post-approval channel will rely on a targeted commercial infrastructure. Given the focus on chronic cough in IPF, non-IPF ILD, and RCC, the sales force will target pulmonologists, ILD specialists, and potentially cough specialists. The company is preparing for the Phase 3 initiation and is focused on building a comprehensive package for the FDA.

The financial resources are in place to support this build-out; the cash position of $194.9 million as of September 30, 2025, is projected to last into 2028. The G&A expenses for Q3 2025 were $3.8 million, an increase from $2.9 million in Q3 2024, partly due to increased personnel-related expenses, which signals early investment in the team required for commercial readiness. The future sales force will be designed to reach the specific, underserved specialist community treating these chronic cough conditions.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Customer Segments

You're looking at the core patient populations Trevi Therapeutics, Inc. is targeting with Haduvio (oral nalbuphine ER) as of late 2025. Honestly, the strategy is laser-focused on high-unmet-need chronic cough indications where current off-label treatments offer minimal relief.

The primary customer segments are the patients themselves, defined by their underlying conditions and the persistence of their cough. We can break down the addressable U.S. patient pool with some precision based on the latest company disclosures.

Customer Segment Type	Condition	Estimated U.S. Patient Population	Key Detail/Unmet Need
Primary Patient Group 1	Chronic Cough in Idiopathic Pulmonary Fibrosis (IPF)	~140,000 patients	Two-thirds of these patients face uncontrolled chronic cough.
Primary Patient Group 2	Refractory Chronic Cough (RCC)	~2-3 million patients	A condition with high unmet need and no FDA-approved therapies.
Secondary Patient Group	Chronic Cough in non-IPF Interstitial Lung Disease (non-IPF ILD)	~228,000 patients	50-60% of this group has uncontrolled chronic cough.

The impact on these patients is significant; for example, some individuals with chronic cough report coughing up to 1,500 times per day, which severely affects their social, physical, and psychological quality of life.

Beyond the patients, Trevi Therapeutics, Inc. must engage with the professional ecosystem that diagnoses and prescribes treatment. These groups are critical for product adoption and market penetration.

• Pulmonologists and cough specialists who treat severe, refractory conditions.
• Allergists/immunologists, as they also treat chronic cough patients.
• Primary care providers, who are often the first point of contact.

The regulatory pathway is a non-negotiable customer segment for any drug developer. You can't sell without their sign-off, so engaging them is a key business activity. Trevi Therapeutics, Inc. is actively working toward this gatekeeper function.

• Regulatory bodies, specifically the FDA, as the gatekeeper for market access.
• Trevi Therapeutics, Inc. is preparing to submit its End-of-Phase 2 meeting request to the FDA in the fourth quarter of 2025.
• The company plans to initiate a comprehensive Phase 3 program for chronic cough in IPF patients by the first half of 2026.

Financially, you should note the company ended the third quarter of 2025 with approximately $194.9 million in cash and marketable securities, which management projects provides a cash runway extending into 2028. This financial footing is what supports the engagement with these customer segments through the next critical clinical steps.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Cost Structure

You're looking at the cost side of Trevi Therapeutics, Inc. (TRVI) as they pivot hard into late-stage development. This is where the cash burn really gets scrutinized, especially with a major Phase 3 program on the horizon.

The most concrete numbers we have come from the third quarter of 2025 financial release. These figures show the current operational baseline before the anticipated ramp-up for pivotal trials.

Cost Category	Q3 2025 Amount	Comparison/Context
Research and Development (R&D) Expenses	$10.1 million	Decreased from $11.2 million in Q3 2024 due to winding down Phase 2 enrollment.
General and Administrative (G&A) Expenses	$3.8 million	Increased from $2.9 million in Q3 2024 due to professional fees and personnel costs.
Net Loss	$11.8 million	Reported for Q3 2025.
Cash and Marketable Securities (as of 9/30/2025)	$194.9 million	Projected cash runway extends into 2028.

The R&D spend is the engine here, but it's set to change. The current $10.1 million in Q3 2025 reflects reduced activity from the recently completed Phase 2a RIVER and Phase 2b CORAL trials. Honestly, that number is about to climb significantly.

Clinical trial costs are the next major variable. Trevi Therapeutics is planning to initiate a comprehensive Phase 3 program for chronic cough in idiopathic pulmonary fibrosis (IPF) patients in the first half of 2026. As the company moves into these larger, later-stage studies, you should definitely anticipate a substantial increase in operating expenses (opex) related to site activation, patient recruitment, and monitoring for these pivotal trials.

Costs associated with manufacturing scale-up and regulatory filings are less explicitly quantified for Q3 2025, but the strategic moves point to where the money is going:

• Preparing for the Phase 3 program initiation in 1H 2026 requires scaling up drug substance and drug product manufacturing capabilities for Haduvio.
• The company is preparing to request an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025, which drives up professional fees within G&A.
• The increase in G&A to $3.8 million in Q3 2025 was partly due to increased professional fees related to preparing for compliance with SOX 404(b) regulations.

To be fair, the current cash position of $194.9 million as of September 30, 2025, is intended to fund these upcoming pivotal trials and secure a runway into 2028. Still, late-stage clinical costs are notoriously high; you'll want to watch the quarterly burn rate closely as they move past the End-of-Phase 2 discussions.

Finance: draft 13-week cash view by Friday.

Trevi Therapeutics, Inc. (TRVI) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Trevi Therapeutics, Inc. (TRVI) as of late 2025, and honestly, it's what you'd expect from a clinical-stage biopharma company focused on a late-stage asset. The primary engine keeping the lights on isn't product sales; it's the capital markets.

Equity financing and capital raises to fund operations (primary source)

The most significant inflow of cash comes from financing activities. You saw a major capital infusion following the positive data from the CORAL trial. Specifically, the company was able to raise approximately $115 million in capital following the data release, bringing the total cash and investments up to approximately $204 million at the end of June 2025. This was a key move to de-risk the path forward. The latest reported cash position, as of September 30, 2025, stood at $194.9 million in cash, cash equivalents, and marketable securities. That level of liquidity supports an expected cash runway extending into 2028, which is definitely a solid footing for the near term.

Interest income from invested cash and marketable securities (Q3 2025: $2.1 million)

Because Trevi Therapeutics, Inc. holds a substantial cash balance from those financing efforts, a secondary, non-operating revenue stream is interest income. For the third quarter of 2025, Other Income, net, which is primarily driven by this interest, increased to $2.1 million. That's up from $0.8 million in the same period in 2024, reflecting both the higher invested balances and prevailing interest rate yields. It's not product revenue, but it helps offset the operating burn.

Here's a quick look at the cash foundation supporting that income stream:

Metric	Amount (as of Q3 2025 End)	Period
Cash, Cash Equivalents, and Marketable Securities	$194.9 million	September 30, 2025
Other Income, net (Interest Income Proxy)	$2.1 million	Q3 2025
Projected Cash Runway	Into 2028	As of Q3 2025

Potential future milestone payments from a commercialization partner

This stream is purely potential right now. Trevi Therapeutics, Inc. is preparing to request an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025 and is planning to initiate the comprehensive Phase 3 program for chronic cough in IPF patients in the first half of 2026. If a commercialization partnership is established before or after Phase 3 success, milestone payments tied to regulatory achievements or clinical progression would become a revenue source. No specific dollar amounts for potential milestones are public, but this is a standard value-inflection point for non-partnered assets.

Future product sales revenue from Haduvio post-FDA approval (currently zero)

As a clinical-stage company, Trevi Therapeutics, Inc. reports zero in product sales revenue for the third quarter of 2025. Revenue generation from Haduvio is contingent on successful completion of the planned Phase 3 program, subsequent FDA approval, and subsequent market launch across its targeted indications, including chronic cough in IPF and refractory chronic cough (RCC). The company is focused on addressing indications where there are currently no approved therapies in the U.S.

Key financial and operational data points related to the revenue-funding structure include:

• Equity financing raised approximately $115 million in capital as of June 2025.
• Cash and investments totaled $194.9 million at the close of Q3 2025.
• Interest income contributed $2.1 million to Other Income, net in Q3 2025.
• Product sales revenue remains at $0, consistent with clinical-stage status.
• The company is preparing to initiate the Phase 3 program for IPF chronic cough in the first half of 2026.

Finance: finalize the Q4 2025 projected cash burn rate based on the planned H1 2026 Phase 3 initiation by end of January.