MannKind Develops Dry Powder Inhalation Formulation Of Ralinepag, Known As Ralinepag DPI, For United Therapeutics

MannKind Corporation
United Therapeutics Corporation

MannKind Corporation

MNKD

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United Therapeutics Corporation

UTHR

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  • The formulation is being developed in collaboration with United Therapeutics Corporation 
  • United Therapeutics made an additional $5 million payment to MannKind to support the rapid advancement of ralinepag DPI
  • United Therapeutics plans to be the primary manufacturer of ralinepag DPI
  • MannKind eligible to receive up to $35 million in development milestones plus 10% royalties on net sales
     

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 06, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products, today announced that it has been developing a dry powder inhalation (DPI) formulation of ralinepag, known as ralinepag DPI (MNKD-1501), for United Therapeutics Corporation (NASDAQ:UTHR), under the companies' expanded license and collaboration agreement announcement from August 2025.

Ralinepag is an investigational prostacyclin receptor agonist that exhibits a long half-life and high potency in the pulmonary vasculature. In March 2026, United Therapeutics reported that its long-term pivotal phase 3 ADVANCE OUTCOMES study of ralinepag extended-release tablets in pulmonary arterial hypertension (PAH) met its primary endpoint with high statistical significance.

Financial Terms and Collaboration Structure

Ralinepag DPI (MNKD-1501) is being advanced under the companies' existing worldwide collaboration agreement, pursuant to which United Therapeutics leads global development, regulatory, and commercialization activities and MannKind supports formulation and supply activities. United Therapeutics made an additional $5 million payment to MannKind in April 2026, to support the rapid advancement of ralinepag DPI. MannKind is eligible to receive up to $35 million in development milestone payments and 10% royalties on net sales of any resulting commercial product.

The original 2018 agreement with United Therapeutics led to the successful development and FDA approval of Tyvaso DPI® in May 2022. In 2025, United Therapeutics reported that Tyvaso DPI generated revenue of $1.3B.

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