MannKind and United Therapeutics Expand Partnership for Second Pulmonary Hypertension Inhaled Therapy
Key Insights
United Therapeutics has exercised its option to develop a second dry powder inhalation therapy using MannKind's Technosphere (search) platform, expanding their successful 2018 collaboration.
The partnership builds on the success of Tyvaso DPI (search), which became the first FDA-approved dry powder inhalation treatment for pulmonary hypertension (search) in May 2022.
MannKind will receive $5 million upfront and is eligible for up to $35 million in development milestones plus 10% royalties on net sales.
United Therapeutics Corporation has exercised its option to develop a second dry powder inhalation therapy in partnership with MannKind Corporation, expanding their successful collaboration that previously delivered the first FDA-approved dry powder treatment for pulmonary hypertension (search). The announcement, made on August 27, 2025, represents a significant milestone in advancing inhaled therapies for patients with serious respiratory conditions.
Expanding a Proven Partnership
The expanded agreement builds upon the companies' original 2018 license and collaboration agreement, which led to the U.S. FDA approval of Tyvaso DPI (search) in May 2022. Under the new terms, MannKind will formulate a second investigational molecule using its proprietary Technosphere (search) platform, while United Therapeutics will conduct preclinical and clinical development activities.
"Building on the success of Tyvaso DPI (search), we are proud to deepen our collaboration with United Therapeutics to bring innovative patient-centric inhaled therapies to patients living with pulmonary hypertension (search)," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "This next step highlights the strength of our partnership and the versatility of our dry powder formulations and inhalation devices in addressing serious respiratory conditions."
Financial Terms and Development Timeline
The expanded collaboration includes substantial financial incentives for MannKind. The company will receive an upfront payment of $5 million and is eligible to receive up to $35 million in development milestones. Additionally, MannKind will earn 10% royalties on net sales of any resulting product that reaches commercialization.
Formulation and development activities for the new investigational molecule will begin immediately, indicating both companies' commitment to advancing the program without delay.
Technosphere Platform's Therapeutic Potential
MannKind's Technosphere (search) platform represents a significant advancement in drug delivery technology for respiratory conditions. The company's dry-powder formulations and inhalation devices offer rapid and convenient delivery of medicines to the deep lung, where they can exert effects locally or enter systemic circulation depending on the target indication.
The platform's versatility extends beyond pulmonary hypertension (search), with MannKind focusing on addressing serious unmet medical needs for patients with endocrine and orphan lung diseases, including diabetes (search), nontuberculous mycobacterial lung disease (search), and pulmonary fibrosis (search).
Clinical Significance for Pulmonary Hypertension
The success of Tyvaso DPI (search) as the first FDA-approved dry powder inhalation treatment for pulmonary hypertension (search) established a new treatment paradigm for patients with this serious condition. The development of a second therapy using the same proven platform could potentially expand treatment options and improve outcomes for patients living with pulmonary hypertension.
The collaboration demonstrates the pharmaceutical industry's continued investment in innovative delivery mechanisms for respiratory therapies, particularly for conditions where traditional treatment approaches may have limitations.