At the 44th annual J.P. Morgan Healthcare conference, Insmed delivered one of the most closely watched updates in the respiratory space, detailing its clinical and commercial plans for 2026. Among the highlights was the company’s announcement to launch a Phase III study for its treprostinil palmitil inhalation powder (TPIP) in progressive pulmonary fibrosis (PPF) during the second half of 2026. If successful, the study could lead to a potential shift in how PPF and other fibrotic disorders are treated, says GlobalData, a leading intelligence and productivity platform.
Connor Daniels, Healthcare Analyst at GlobalData, comments: “The announcement demonstrates Insmed’s pivot towards fibrotic lung diseases alongside its established late-stage programs in pulmonary hypertension and other respiratory conditions. TPIP’s expansive Phase III development, encompassing pulmonary hypertension associated with interstitial lung disease (PH-ILD), pulmonary arterial hypertension, PPF, and idiopathic pulmonary fibrosis (IPF), represents an ambitious registrational effort.”
PPF is a clinical phenotype that describes worsening fibrosis in the lung over time after an ILD diagnosis, despite treatment. PPF refers to a broad set of fibrotic ILDs characterized by declining lung function, worsening symptoms, and increasing evidence of fibrosis on high-resolution computed tomography (CT) scans.
Current approved anti-fibrotic agents, such as Boehringer Ingelheim’s Ofev (nintedanib) and Jascayd (nerandomilast), have demonstrated efficacy in slowing disease progression but do not stop or reverse fibrosis, and patients continue to experience gradual declining respiratory function and increased morbidity, highlighting the unmet need in this area.
The field of PPF research is moving rapidly, as demonstrated by the approval of Boehringer Ingelheim’s asset Jascayd in the US at the end of last year, cementing the company’s position as the leader in this field with two marketed therapies. Nevertheless, the need for disease-modifying therapies remains. As a result, many investigational programs are ongoing to explore novel targets to slow fibrosis, such as the lysophosphatidic acid receptor 1 antagonist admilparant by Bristol Myers Squibb and the prostacyclin receptor agonist Tyvaso (Treprostinil) by United Therapeutics, both of which are in Phase III clinical trials.
Daniels adds: “However, few assets are currently in Phase III trials due to the heterogeneous nature of PPF makes it difficult to identify specific targets that will be effective in broad patient populations. This variability also makes it challenging to design clinical trials with appropriate endpoints to clearly demonstrate the efficacy of potential assets.”
Looking ahead, Insmed’s decision to launch a Phase III study of TPIP in PPF could be transformative if it can demonstrate efficacy and safety as an antifibrotic to treat PPF. TPIP’s mechanism, a once-daily inhaled prostanoid with the potential to exert anti-fibrotic effects, would offer a differentiated profile compared to other antifibrotics, due to its inhaled route of administration.
Daniels concludes: “If Phase III trials are successful, TPIP could become an important addition to the treatment paradigm for PPF and other fibrotic lung diseases, expanding the therapeutic options available to patients who currently have limited options to alter their prognosis. Furthermore, success in PPF trials may lead the way for further combination trials that pair the current antifibrotic standard of care with innovative inhaled therapies.”
