MannKind and United Therapeutics Expand Ralinepag DPI Program for Pulmonary Hypertension and Fibrotic Lung Diseases
Event summary
- MannKind and United Therapeutics are developing a dry powder inhalation (DPI) formulation of ralinepag (MNKD-1501) for pulmonary hypertension and fibrotic lung diseases.
- 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 milestones plus 10% royalties on net sales of any resulting commercial product.
- United Therapeutics plans to be the primary manufacturer of ralinepag DPI and intends to seek approval for pulmonary arterial hypertension (PAH) first.
- The collaboration builds on the successful development and FDA approval of Tyvaso DPI®, which generated $1.3B in revenue in 2025.
The big picture
This collaboration underscores the strategic importance of inhaled therapeutics in treating pulmonary diseases, building on the success of Tyvaso DPI. The partnership leverages MannKind's expertise in DPI formulations and United Therapeutics' leadership in pulmonary hypertension treatments. The potential expansion into fibrotic lung diseases represents a significant growth opportunity for both companies in a high-need market.
What we're watching
- Execution Risk
- Whether MannKind can successfully formulate ralinepag DPI to meet United Therapeutics' non-clinical and clinical study requirements.
- Market Potential
- The pace at which ralinepag DPI can gain approval and commercialization for PAH and other fibrotic lung diseases.
- Financial Upside
- How the $35 million in development milestones and 10% royalties on net sales will impact MannKind's revenue stream.
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