What Respira Therapeutics does

Respira Therapeutics is a clinical-stage biopharmaceutical company founded in 2010 and headquartered in Palo Alto, California, developing next-generation inhaled therapies for cardiopulmonary diseases. The company is built around a proprietary drug-device platform combining the AOS™ (Axial Oscillating Sphere) Dry-Powder Inhaler, which uses four distinct dispersion elements to target the lung periphery, with advanced particle engineering formulations. Its lead candidate, RT234-PAH, is a first-in-class reformulation of vardenafil (a potent PDE5 inhibitor) as an inhalation powder intended for "as-needed" (PRN) use in patients with Pulmonary Arterial Hypertension (PAH). The company is also developing RT234-ILD PH for Pulmonary Hypertension associated with Interstitial Lung Disease (WHO Group 3.2). Respira has received FDA Orphan Drug designation for vardenafil in PAH and is pursuing approval via the 505(b)(2) regulatory pathway.

The company's business model is pre-commercial: Respira generates no product revenue and instead derives value from advancing clinical assets and from strategic partnership and licensing arrangements. As a 1-10 employee venture-backed entity (currently owned by Samsara BioCapital), the company selectively partners with pharmaceutical firms facing unique pulmonary delivery challenges. In September 2025, Respira entered an agreement with Gossamer Bio granting Gossamer an option to acquire the company and its inhaled vardenafil candidate. End-customers are PAH and ILD-PH patient populations (~30,000 each in the U.S.) in an estimated $8B global PAH treatment market; commercialization would route through standard pharmaceutical distribution and specialty pulmonary channels following FDA approval.

Leadership combines deep drug-device commercialization and inhaled delivery expertise, including CEO John Kollins (ex-Satsuma Pharmaceuticals CEO), Chairman William Fairey (former Actelion US President, ex-MyoKardia CCO), and board member Michael Riebe (former VP of Inhalation Product Development at AstraZeneca). Backed by Cottonwood Technology Fund, Sun Mountain Capital, Keiretsu Forum Northwest, and Samsara BioCapital, Respira has raised approximately $5.1M-$6.1M in disclosed equity financing through 2015 and is operating with Phase 2b VIPAH-PRN clinical data presented at ATS 2025 as its most recent substantive milestone.

Name

Respira Therapeutics

Legal name

Respira Therapeutics Inc.

Website

https://respiratherapeutics.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

1–10 employees

Short description

Respira Therapeutics is a clinical-stage biopharmaceutical company developing first-in-class inhaled vardenafil therapies via its proprietary AOS™ Dry-Powder Inhaler for patients with Pulmonary Arterial Hypertension and ILD-associated Pulmonary Hypertension, currently pre-revenue and subject to a Gossamer Bio acquisition option.

Ownership category

akta.pro rank

Product category

Inhaled Pulmonary Therapeutics

NAICS

Pharmaceutical and Medicine Manufacturing (32541), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Rare Renal & Nephrology Disorder Therapies (HLAIAIAI)

akta.pro secondary industries

Pulmonology & Allergy Specialty Pharmaceuticals (HLAIACAF), Inhalers (MDI/DPI/SMI) (HLAHAIAI), Rare Cardiovascular & Vascular Disorder Therapies (HLAIAIAH)

Keywords

• Inhaled drug delivery
• Dry powder inhalers
• Pulmonary hypertension therapy
• Pharmaceutical drug development
• Vardenafil inhalation powder

Headquarters

HQ city

Albuquerque

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Infrastructure

Revenue model

1. Pharmaceutical Product Sales: Pre-revenue clinical-stage company. Expected to commercialize RT234-PAH and RT234-ILD PH upon FDA approval. Product is first-in-class inhaled therapy for PAH patients, contrasting with chronic treatment regimens of existing therapies.
2. Strategic Partnerships and Licensing: Company selectively partners with pharmaceutical companies having unique pulmonary delivery challenges. Agreement with Gossamer Bio grants option to acquire Respira and its inhaled vardenafil product candidate.
3. Future Product Pipeline: Pipeline includes wholly owned development candidates with anticipation to launch additional product development programs. Focus on 505(b)(2) products that may improve standard of care.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels3 records

Core offering

Respira Therapeutics is a clinical-stage biopharmaceutical company developing inhaled drug-device combination products for cardiopulmonary diseases. Its lead candidate RT234-PAH is a first-in-class inhaled vardenafil dry powder formulation delivered via the proprietary AOS™ Dry-Powder Inhaler (DPI), intended for as-needed (PRN) use in patients with Pulmonary Arterial Hypertension (PAH). The company also develops RT234-ILD PH for Pulmonary Hypertension associated with Interstitial Lung Disease and pursues 505(b)(2) regulatory pathways.

Product overview

Respira Therapeutics is a clinical-stage biopharmaceutical company developing next-generation cardiopulmonary disease-targeted inhalation products. The company operates a platform combining its proprietary AOS™ dry-powder inhaler (DPI) device with advanced particle engineering-based inhaled drug formulations to enhance drug delivery to the lung periphery. The core product portfolio includes RT234-PAH (vardenafil inhalation powder) for Pulmonary Arterial Hypertension treatment on an as-needed basis, and RT234-ILD PH for Pulmonary Hypertension associated with Interstitial Lung Disease. All products utilize the AOS DPI device as the delivery mechanism.

Differentiator

Problem solved

Functional benefit

Brands

• RT234-PAH: First-in-class inhaled therapy intended for as-needed (PRN) use to improve exercise tolerance and provide acute relief from breathlessness and fatigue in pulmonary arterial hypertension (PAH) patients.
• RT234-ILD PH
• AOS DPI (Axial Oscillating Sphere Dry Powder Inhaler)

Products and services

• RT234-PAH First-in-class inhaled therapy (vardenafil inhalation powder) for Pulmonary Arterial Hypertension (PAH), intended for as-needed (PRN) use to improve exercise tolerance and provide acute relief from breathlessness and fatigue. Delivered via the AOS DPI device. Currently in Phase 2 clinical trials.
• RT234-ILD PH Inhaled vardenafil therapy in development for treatment of Pulmonary Hypertension in Interstitial Lung Disease, targeting breathlessness, fatigue, and exercise capacity in ILD patients with elevated pulmonary artery pressures.
• AOS DPI (Axial Oscillating Sphere Dry Powder Inhaler) Proprietary capsule-based dry powder inhaler device with four distinct dispersion elements designed for efficient pulmonary drug delivery to the lung periphery. Core enabling technology for the RT234 drug-device combination products.

Quantifiable outcome

• Phase 2b clinical trial demonstrated acute improvement in exercise capacity and reduced dyspnea in PAH patients
• +3 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core.

• Gossamer BiocoreStrategic or Co-development Partner · 25 September 2025Gossamer Bio entered into an agreement granting them option to acquire Respira Therapeutics and its inhaled vardenafil product candidate (RT234). This represents a significant strategic transaction for Respira, potentially leading to full acquisition. Gossamer is developing seralutinib for pulmonary hypertension conditions.
• FDA (Orphan Drug Designation)coreOthersFDA has granted Orphan Drug designation for vardenafil (active ingredient in RT234) for the treatment of Pulmonary Arterial Hypertension. This designation provides incentives including potential market exclusivity and regulatory support.

Scale indicators4 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Aerogen: Specializes in aerosol drug delivery technologies for respiratory care, sharing Respira's focus on advanced pulmonary drug delivery device innovation for critical care applications.
• United Therapeutics: Market leader in Pulmonary Arterial Hypertension therapies (Tyvaso, Remodulin, Orenitram), directly competing in the same PAH market that Respira targets with RT234-PAH.
• Gossamer Bio: Clinical-stage biopharma developing seralutinib for pulmonary hypertension and has an option to acquire Respira Therapeutics, representing both a peer in PAH drug development and a strategic acquirer.
• Liquidia Technologies: Clinical-stage company developing inhaled treprostinil (YUTREPIA) for PAH and pulmonary hypertension associated with interstitial lung disease, directly competing with Respira's RT234-ILD PH program.
• MannKind Corporation: Develops inhaled drug-device combination products (Afrezza) using proprietary dry-powder inhalation technology, sharing Respira's drug-device inhalation platform focus and clinical-stage biopharma profile.
• Vectura Group: Specializes in inhaled drug delivery including dry-powder inhaler technology development and licensing, operating a similar business model of developing DPI-based therapies for respiratory diseases.

Broad incumbents

• Insmed: Established biopharma with ARIKAYCE for lung infections and growing pipeline in pulmonary diseases including inhaled therapies, representing a larger incumbent in the inhaled respiratory drug space.
• Actelion Pharmaceuticals (Johnson & Johnson): Historical PAH market leader (now part of J&J), maker of Tracleer, Opsumit, and Uptravi that established chronic PAH treatment paradigms Respira's PRN approach must differentiate against.

Emerging players

• Pulmatrix: Clinical-stage company developing inhaled therapies for pulmonary diseases using proprietary iSPERSE technology, overlapping with Respira's particle engineering and inhaled drug delivery focus.
• Phase Bio Pharmaceuticals: Clinical-stage biopharma developing therapeutics including inhaled formulations for cardiopulmonary conditions, sharing Respira's focus on vascular and pulmonary drug delivery.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/respira-therapeutics

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Funding overview

Funding rounds5 records

Investors3 records

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 Respira Therapeutics