MannKind Secures $5M Advance and Potential $35M Milestones for Ralinepag DPI Program
MannKind received a $5 million advance payment from United Therapeutics under their DPI collaboration for ralinepag, with potential milestone payments up to $35 million and 10% royalties on net sales. United Therapeutics will lead development and manufacturing of the dry powder formulation, advancing toward phase 1 trials and pulmonary indications.
1. Collaboration Expansion
MannKind and United Therapeutics expanded their 2025 collaboration to include ralinepag dry powder inhalation (MNKD-1501) for pulmonary hypertension and fibrotic lung diseases. Under the agreement, United Therapeutics will lead regulatory, development and manufacturing efforts, while MannKind provides formulation and supply expertise.
2. Development and Clinical Plans
Ralinepag DPI is currently being formulated for planned non-clinical studies, followed by a phase 1 pharmacokinetic trial in healthy volunteers to compare dosing with oral tablets. Positive results will inform a pivotal study in PAH patients, with additional trials planned for pulmonary hypertension associated with interstitial lung disease, idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.
3. Financial Terms and Strategic Impact
In April 2026, United Therapeutics paid MannKind $5 million to accelerate the program, with up to $35 million in future development milestones and 10% royalties on net sales. The original 2018 agreement led to the $1.3 billion 2025 revenue from Tyvaso DPI, underscoring MannKind’s value in inhaled drug-device partnerships.