What Pulmovant does

Pulmovant is a clinical-stage biotechnology company founded in 2023 as a wholly-owned subsidiary of Roivant Sciences (NASDAQ: ROIV), singularly focused on developing therapies for pulmonary diseases. The company is headquartered in Waltham, Massachusetts, operates with 11–50 employees, and is led by a management team with deep inhaled-drug-development credentials drawn from AstraZeneca, Acceleron, Eli Lilly, Actelion, and Idorsia. Its lead and only clinical asset is mosliciguat (BAY 1237592), a potential first-in-class, once-daily, inhaled soluble guanylate cyclase (sGC) activator being developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD), a WHO Group 3 condition affecting up to 200,000 patients in the US and Europe with limited approved treatment options.

Mosliciguat's mechanism is differentiated from existing sGC stimulators in that it acts independently of heme and nitric oxide, preserving enzymatic activity in the oxidative environments characteristic of PH-ILD. The compound is formulated for delivery via a low-resistance dry powder inhaler (DPI) requiring only a single inhalation per day, contrasting with multiple-dose nebulized or multi-inhalation inhaled PH therapies. Clinical progress to date includes a Phase 1 program spanning 170 participants showing favorable safety, dose-dependent cGMP increases, and a 40-hour half-life; a Phase 1b ATMOS study in 38 PH patients demonstrating mean peak PVR reductions of up to 38%; and two ongoing Phase 2 trials — the global PHocus monotherapy study (NCT06635850, ~120 participants, enrollment completed in under 12 months) and the PHactor combination study with inhaled treprostinil.

Pulmovant is pre-revenue and operates a pre-commercial business model: capital is sourced through its Roivant parent, and future revenue is expected to come from pharmaceutical product sales following regulatory approval. The company received Japan MHLW orphan drug designation for mosliciguat in September 2025, providing up to 10 years of post-approval market exclusivity. Anticipated go-to-market relies on specialty pharmacy networks and hospital-based field sales targeting PH specialists and pulmonologists across the US and EU, with topline Phase 2 data expected in the second half of calendar year 2026 as the next value-defining catalyst.

Name

Pulmovant

Legal name

Pulmovant, Inc.

Website

https://pulmovant.com

Company type

Private

Founded year

2023

Operating status

Operating

Headcount range

51–100 employees

Short description

Pulmovant is a clinical-stage biotechnology subsidiary of Roivant Sciences developing mosliciguat, a potential first-in-class once-daily inhaled sGC activator for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Ownership category

akta.pro rank

Product category

Pulmonary Hypertension Therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414), Scientific Research and Development Services (5417)

SIC

Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Pulmonary Hypertension & Rare Pulmonary Disease Therapies (HLAIAIAG)

akta.pro secondary industries

Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE), Pulmonology & Allergy Specialty Pharmaceuticals (HLAIACAF)

Keywords

• Pulmonary hypertension therapies
• Respiratory disease treatments
• Inhaled drug delivery
• Clinical-stage biotechnology
• Orphan drug development

Headquarters

HQ city

Waltham

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pharmaceutical Product Revenue: As a clinical-stage biotech, Pulmovant is pre-revenue. The company is developing mosliciguat for PH-ILD, a rare disease indication with orphan drug designation. Future revenue will come from pharmaceutical product sales upon regulatory approval. PH-ILD affects up to 200,000 patients in U.S. and Europe with limited to no approved treatment options, representing an attractive commercial opportunity.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Pulmovant is a clinical-stage biotechnology company developing mosliciguat (BAY 1237592), a potential first-in-class, once-daily, inhaled soluble guanylate cyclase (sGC) activator for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). The drug is delivered via a low-resistance dry powder inhaler requiring a single inhalation per day, with a differentiated mechanism of action that functions independently of heme and nitric oxide. The company is running the Phase 2 PHocus monotherapy trial and the Phase 2 PHactor combination trial with inhaled treprostinil, and holds orphan drug designation in Japan.

Product overview

Pulmovant is a clinical-stage biotechnology company developing a single investigational product, mosliciguat, for pulmonary hypertension associated with interstitial lung disease (PH-ILD). Mosliciguat is a potential first-in-class, once-daily, inhaled sGC activator delivered via dry powder inhaler. The company's development pipeline includes the Phase 2 PHocus study for monotherapy and the Phase 2 PHactor study for combination therapy with inhaled treprostinil. The product completed Phase 1b ATMOS proof-of-concept study demonstrating up to 38% reduction in pulmonary vascular resistance.

Differentiator

Problem solved

Functional benefit

Products and services

• Mosliciguat (BAY 1237592) Mosliciguat (BAY 1237592) is a potential first-in-class, once-daily, inhaled soluble guanylate cyclase (sGC) activator designed for targeted pulmonary vasodilation with limited systemic side effects in the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). It is delivered via a low-resistance dry powder inhaler as a lactose carrier-based formulation requiring only a single inhalation per day.

Quantifiable outcome

• Mean peak PVR reduction of up to 38% in Phase 1b ATMOS study - one of the highest reductions seen in PH trials to date
• +4 more outcomes

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Emerging players

• Gossamer Bio: Gossamer Bio is developing seralutinib, an inhaled kinase inhibitor for PAH and PH-ILD. While mechanism-distinct (tyrosine kinase vs sGC activator), Gossamer targets the same inhaled PH-ILD niche and represents another late-stage competitive entrant.
• Altavant Sciences: Altavant is a Roivant-affiliated Vant focused on rare pulmonary diseases, including PH-ILD. It is the closest sibling company within the Roivant portfolio and is structured similarly as a thinly-resourced, single-asset clinical-stage biotech targeting pulmonary hypertension indications.

Direct peers

• Liquidia Corporation: Liquidia is a PH-focused biopharmaceutical company with an inhaled treprostinil program (YUTREPIA) targeting PAH and PH-ILD. It competes for the same physician-prescriber base and specialty distribution channel that Pulmovant plans to enter.
• Aerovate Therapeutics: Aerovate Therapeutics is developing an inhaled dry powder formulation of imatinib for PH-ILD. It is the most direct competitor to Pulmovant's mosliciguat, addressing the same patient population with an inhaled lung-targeted approach and competing for the same specialty pharmacy channel.

Broad incumbents

• United Therapeutics: United Therapeutics markets Tyvaso DPI (inhaled treprostinil), which is FDA-approved for PH-ILD and serves as the on-market benchmark Pulmovant must displace. UTHR is a well-capitalized incumbent with established physician relationships across the PH specialist community.
• Bayer (Adempas/riociguat): Bayer developed and markets Adempas (riociguat), a systemic sGC stimulator approved for PAH and CTEPH. Bayer also originally developed mosliciguat before it was licensed into Pulmovant, making it both the originator of the compound and the established sGC-modulation reference product.
• Johnson & Johnson (Actelion): J&J's Actelion franchise markets Opsumit, Tracleer, and Uptravi — the foundational PAH and CTEPH therapies that Pulmovant leadership (e.g., Amy Yoney, Brian Schlag) previously worked on. The franchise defines physician algorithms Pulmovant will position mosliciguat against.
• Insmed Incorporated: Insmed is a specialty biopharma company with a respiratory franchise (Arikayce for nontuberculous mycobacterial lung disease) and is advancing pulmonary programs. It represents a comparable specialty-pulmonary commercial infrastructure against which Pulmovant's eventual go-to-market will be benchmarked.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights6 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Pulmovant