Admilparant approval for idiopathic pulmonary fibrosis (IPF) is not yet decided, and LSDN found no announced regulatory filing. On 12 October 2026, Bristol Myers Squibb (BMS) reported that its phase 3 ALOFT-IPF trial met its primary endpoint. That was at the 60 mg twice-daily dose. The 120 mg dose did not reach statistical significance. The company has not yet published the size of the effect.
The result matters because the question readers will still ask in a month is practical. Will this oral drug reach patients, and when? Admilparant approval depends on steps that have not yet happened. The release answers only part of that. The sections below set out what is known, what is not, and what would settle it.
What did the ALOFT-IPF trial report on 12 October 2026?
BMS announced the topline result in a Business Wire release datelined Princeton, New Jersey. The trial is a multicentre, randomised, double-blind, placebo-controlled phase 3 study. It enrolled about 1,255 adults aged 40 or older with IPF.
Participants were randomised 1:1:1 to 60 mg twice daily, 120 mg twice daily or placebo. Treatment lasted at least 52 weeks. The registered identifier for the study is NCT06003426.
The primary endpoint was the change in forced vital capacity (FVC) from baseline to week 52. At 60 mg, BMS reported a statistically significant improvement compared with placebo. At 120 mg, FVC decline also slowed, but the difference was not statistically significant.
BMS said admilparant was well tolerated at both doses. It said discontinuations due to adverse events were low and similar to placebo. As read by LSDN on 12 October, the release gives no FVC values in millilitres. It also gives no numeric adverse event rates.
In the company statement, Cristian Massacesi called the profile “promising” and “clinically meaningful”. He is BMS chief medical officer and head of development. Fernando Martinez, chair of the ALOFT clinical steering committee, said patients need therapies that are both effective and tolerable.
What BMS says happens next
BMS said it will complete a full evaluation of the data. It will also work with health authorities on planned regulatory submissions. Detailed results will follow at a future medical meeting, and the release names no date.
A companion phase 3 trial, ALOFT-PPF (NCT06025578), covers progressive pulmonary fibrosis (PPF). It is fully enrolled with about 1,057 adults. BMS expects topline results in early 2027.
Does the 120 mg result weaken admilparant approval?
The release does not explain why the higher dose missed significance. That gap matters for any label, because regulators set a dose from the trial evidence. LSDN found no BMS statement on which dose it would take forward.
The 60 mg dose is also the one behind BMS’s phase 2 figures. BMS reports a 62 per cent cut in the rate of lung function decline versus placebo in IPF. That was over 26 weeks. The figure was 69 per cent in PPF. These phase 2 numbers come from smaller studies and do not predict the phase 3 effect size.
Admilparant is an oral LPA1 antagonist, which BMS describes as an antifibrogenic approach. In October 2023, BMS announced the FDA had granted Breakthrough Therapy Designation to BMS-986278, now named admilparant, for PPF. That designation covers PPF, and LSDN found no announcement of one for IPF.
What is the liver safety question around admilparant?
The BMS release calls admilparant well tolerated. A separate set of reports adds context that the release does not address. Any reader weighing admilparant approval needs both.
What the protocol amendment says
BioPharma Dive reported on 30 September 2026 that BMS submitted a protocol amendment for its European sites in May. It covers the long-term safety extension of the ALOFT programme. The amendment lists liver injury as a “newly classified important potential risk”. Patients with abnormally high liver enzymes now receive closer monitoring.
A BMS spokesperson confirmed a limited number of liver-related events, including one death. Fierce Biotech reported the same facts on 1 October. BMS said most events were mild or transient. BMS said an independent data monitoring committee has each time recommended continuing the study.
What remains unknown
BMS management has since told William Blair analysts that the fatal case occurred in the 120 mg arm. Fierce Biotech and BioSpace reported the note on 12 October. An adjudication committee judged the death “unlikely related to study treatment”, the analysts said. The fatal case involved multi-organ failure with liver damage, according to the amendment as reported. The patient had underlying lung disorders and other complications, BioPharma Dive reported.
Analysts were divided in tone. Leerink Partners analyst Roanna Ruiz wrote in a note that it “may not be a drug-related issue”. BioPharma Dive also notes that BMS stopped an earlier LPA1 drug over liver toxicity. Amgen also shelved an LPA1 programme inherited from Horizon Therapeutics, after a lung disease study missed its endpoints.
The 12 October release, as read by LSDN, reports no liver enzyme data. Whether the full dataset settles the question depends on the safety tables BMS plans to present. Those tables will shape admilparant approval as much as the efficacy data.
How does admilparant compare with nerandomilast in IPF?
No fair comparison is possible yet. The nearest reference is nerandomilast (Jascayd), from Boehringer Ingelheim. The Pulmonary Fibrosis Foundation reported that the FDA approved it for IPF on 7 October 2025.
In the UK, the MHRA approved nerandomilast on 8 July 2026 for adults with IPF and PPF. The recommended dose is an 18 mg tablet twice a day. Julian Beach, MHRA Executive Director, Healthcare Quality and Access, said it provides “a new treatment option”.
The phase 3 FIBRONEER-IPF trial, published in the New England Journal of Medicine, randomised 1,177 patients. Of these, 77.7 per cent were taking nintedanib or pirfenidone at enrolment. The adjusted mean FVC change at week 52 was -114.7 mL on 18 mg and -183.5 mL on placebo.
That is a difference of 68.8 mL (95% confidence interval 30.3 to 107.4). Diarrhoea occurred in 41.3 per cent on 18 mg and 16.0 per cent on placebo. The registered identifier is NCT05321069.
BMS has not published an equivalent FVC figure for admilparant. Trial populations, background therapy and designs also differ. LSDN therefore does not rank the two drugs.
What would admilparant approval mean for UK patients?
For now, nothing changes for UK patients. LSDN found no announced MHRA or European Medicines Agency application for admilparant. LSDN also found no NICE project for it, so UK admilparant approval has no timetable.
NICE offers a useful marker from the nearest comparator. Its project page for nerandomilast lists a single technology appraisal. On 12 October 2026, the page still showed an expected publication date of 9 September 2026. It showed no published guidance and a latest update dated 5 December 2025.
That page may lag the appraisal itself. It does show how long NHS access can trail a licence. Any admilparant appraisal would start from a later point, and UK access would follow admilparant approval by the MHRA.
IPF is a serious disease. BMS says about 1.4 million people live with it worldwide. It puts median survival for pulmonary fibrosis at three to five years after diagnosis. Those figures explain the demand for new options, though they do not predict approval.
When will admilparant approval be decided?
No one can say yet. Admilparant approval depends on steps that have not happened. Four events would move the answer.
First, BMS must present the full ALOFT-IPF data, including FVC in millilitres. Second, the liver safety picture must hold across both phase 3 trials. Third, BMS must announce a filing and a regulator must accept it. Fourth, ALOFT-PPF must report in early 2027.
Other IPF candidates are moving too. LSDN’s coverage of AI-discovered drugs notes that rentosertib entered phase 3 in IPF in July 2026. LSDN also tracks regulatory timelines on its FDA drug approval decisions page.
For now, the supportable summary is narrow. One dose met a statistical bar, one did not, and the effect size is unpublished. Safety reporting is incomplete, and no filing has been announced.
