MannKind Corporation announced that it is developing a DPI formulation of MNKD-1501 ralinepag for the treatment of pulmonary arterial hypertension under an agreement with United Therapeutics under a 2018 licensing and collaboration agreement between the companies that initially covered development of Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH). The companies said that they plan to develop MNKD-1501 for the treatment of PH-ILD, IPF, and PPF in the future.
In August 2025. the companies announced an expansion of the agreement for development of a second dry powder inhaler. According to the announcement, United Therapeutics paid MannKind $5 million in April 2026 for services related to development of the ralinepag DPI, and MannKind could be eligible for up to $35 million in milestone payments and royalties.
MannKind CEO Michael Castagna commented, “We have been working on the ralinepag DPI formulation for the past six months and are excited to finally be able to share this announcement. We are pleased to apply our dry powder development expertise to advance ralinepag DPI. This program further validates MannKind’s role as a partner of choice for inhaled delivery of complex and high-value therapeutics.”
United Therapeutics Chairperson and CEO Martine Rothblatt said, “Supported by the strength of the pivotal ADVANCE OUTCOMES results, we believe ralinepag has the potential to redefine the PAH treatment landscape, and we view ralinepag DPI as an important component of long-term success to help broaden real-world use and support patients over time.”
Read the MannKind Corporation press release
