Admilparant

If its Phase 3 trials succeed, admilparant would bring a new mechanism, LPA1 blockade, alongside the 3 approved IPF drugs: pirfenidone, nintedanib and nerandomilast (Jascayd). ALOFT-IPF allows patients to stay on nintedanib or pirfenidone.

Lysophosphatidic acid (LPA) is a fat-based signaling molecule, and signaling through its receptor LPA1 is fundamental to how scarring develops in fibrotic lung diseases, according to the BMS-supported team that designed the Phase 3 trial^[3]. Admilparant blocks LPA1, with the aim of slowing the scarring that steadily reduces lung capacity in IPF^[1]. The Phase 3 trials measure whether it slows the yearly loss of lung capacity, measured as forced vital capacity (FVC), the amount of air the lungs can blow out^[4].

Admilparant is investigational, so there is no FDA label. In the published Phase 2 trial, diarrhea occurred at similar rates on admilparant and placebo. Blood pressure dropped for a short time after the first dose in every group, but more with admilparant. In the progressive pulmonary fibrosis group, side effects led 2.5% on 30 mg and 0% on 60 mg to stop treatment, against 17.1% on placebo, and in the IPF group, stopping rates were similar across groups^[1]. Each Phase 3 trial began with a smaller safety group whose main measure was fainting episodes during about the first 4 weeks^[3][4].

Not approved; available only in clinical trials, and both Phase 3 trials were listed as not recruiting on September 29, 2026. ALOFT-IPF enrolled adults 40 and older with IPF diagnosed within 7 years, percent predicted FVC of at least 40% and DLCO (a test of oxygen transfer) of at least 25%, and allowed stable nintedanib or pirfenidone. ALOFT-PPF enrolled adults 21 and older with progressive fibrosing lung disease other than IPF.

Source: ALOFT-IPF on ClinicalTrials.gov (not recruiting)

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The Phase 2 trial (NCT04308681), published in the American Journal of Respiratory and Critical Care Medicine in February 2025, randomized 278 people with IPF and 125 with progressive pulmonary fibrosis (PPF) to admilparant 30 mg, 60 mg or placebo twice daily for 26 weeks. Percent predicted FVC compares lung capacity with what is expected for a person's age, sex and height. In IPF, it fell 1.2 percentage points on 60 mg against 2.7 on placebo, a difference of 1.4 points with a statistical range (-0.1 to 3.0) that includes no difference, while on the 30 mg dose it fell 2.8 points, no better than placebo. In PPF, it fell 1.1 points on 60 mg against 4.3 on placebo, a difference of 3.2 points. The effect was seen with or without background antifibrotic drugs^[1]. A later analysis, not planned in advance, found that 60 mg delayed disease progression over 26 weeks in both groups^[2]. ALOFT-IPF (NCT06003426) is a Phase 3, double-blind, placebo-controlled trial in adults 40 and older with IPF diagnosed within the past 7 years. A small first cohort tests safety, with fainting episodes after about 4 weeks as its primary endpoint, and the main cohort's primary endpoint is the change in FVC, in mL, over 52 weeks. On September 29, 2026, ClinicalTrials.gov listed 1,255 people enrolled, status active, not recruiting, and primary completion estimated for October 6, 2026^[4][3]. ALOFT-PPF (NCT06025578) uses the same 2-cohort design and primary endpoints in adults 21 and older with progressive fibrosing lung disease other than IPF; the record listed an estimated 1,057 participants, status active, not recruiting, and primary completion estimated for December 27, 2027^[5]. In its July 30, 2026 investor presentation, BMS listed ALOFT-IPF data as expected in 2026 and ALOFT-PPF data in 2027^[6].

Bristol Myers Squibb developed admilparant under the code BMS-986278 and published the Phase 2 results in February 2025^[1]. ALOFT-IPF began enrolling on September 14, 2023 and ALOFT-PPF on October 25, 2023, according to ClinicalTrials.gov^[4][5]. On July 30, 2026, BMS listed ALOFT-IPF among its registrational readouts expected in 2026 and ALOFT-PPF among those expected in 2027, noting that such timelines are forward-looking^[6].

IPF has 3 approved antifibrotic drugs, pirfenidone, nintedanib and nerandomilast (Jascayd, approved October 2025). All 3 slow the decline in lung function. Admilparant is being tested both alone and on top of nintedanib or pirfenidone.