MEDISEARCHER NEWS
Global · Pulmonary fibrosis · 14 October 2026
In brief
- Admilparant, an experimental oral treatment for idiopathic pulmonary fibrosis (IPF), has met the primary endpoint in a pivotal Phase 3 clinical trial.
- The 60 mg twice-daily dose produced a statistically significant benefit in lung function at 52 weeks compared with placebo.
- The higher 120 mg twice-daily dose slowed lung-function decline but did not achieve statistical significance.
- The trial involved approximately 1,255 adults with IPF, making this late-stage evidence rather than an early experimental finding.
- Admilparant is not yet an approved treatment. Bristol Myers Squibb plans to discuss the results with health authorities ahead of regulatory submissions.
- Important details, including the size of the Phase 3 treatment effect and full secondary endpoint data, have not yet been publicly reported.
A potential new treatment for idiopathic pulmonary fibrosis has passed a major late-stage clinical trial milestone, with admilparant meeting the primary endpoint in the pivotal Phase 3 ALOFT-IPF study.
Bristol Myers Squibb announced on 12 October 2026 that the 60 mg twice-daily dose of admilparant produced a statistically significant benefit compared with placebo in the absolute change in forced vital capacity (FVC) from baseline to 52 weeks.
FVC measures how much air a person can forcibly exhale after taking a full breath and is an important measure of declining lung function in idiopathic pulmonary fibrosis.
The result is potentially significant because IPF causes progressive and irreversible scarring of the lungs. Existing antifibrotic treatments can slow disease progression, but they do not cure the condition.
Admilparant is still an investigational medicine and has not yet been approved for the treatment of IPF. The Phase 3 announcement is therefore an important development rather than evidence that a new treatment is immediately available to patients.
What did the Phase 3 admilparant trial find?
ALOFT-IPF is a Phase 3, multicentre, randomised, double-blind, placebo-controlled trial involving approximately 1,255 adults aged 40 years or older with idiopathic pulmonary fibrosis.
Participants were assigned to receive admilparant at 60 mg twice daily, admilparant at 120 mg twice daily, or placebo for at least 52 weeks.
The primary endpoint was the absolute change from baseline in forced vital capacity at Week 52.
According to the topline results released by Bristol Myers Squibb, the 60 mg dose met that endpoint and produced a statistically significant improvement compared with placebo.
However, the result was not replicated at the higher dose. Admilparant 120 mg twice daily slowed the decline in FVC compared with placebo, but the difference did not reach statistical significance.
That distinction is important. The trial can legitimately be described as having met its primary endpoint at the 60 mg dose, but the results do not show that increasing the dose produced a greater treatment effect.
How much did admilparant slow lung-function decline?
We do not yet know from the Phase 3 results.
Bristol Myers Squibb’s initial announcement reported that the difference between the 60 mg dose and placebo was statistically significant, but it did not disclose the actual FVC changes in each treatment group, the size of the between-group difference, confidence intervals or detailed results for secondary endpoints.
Those numbers will be important when assessing how clinically meaningful the result is for people living with IPF.
The company says it will complete a comprehensive evaluation of the ALOFT-IPF data and present detailed results at a future medical meeting.
Until those data are available, the Phase 3 result should be regarded as promising but incomplete.
What is admilparant?
Admilparant, previously known as BMS-986278, is an investigational oral medicine designed to block lysophosphatidic acid receptor 1, usually abbreviated as LPA1.
Lysophosphatidic acid signalling is involved in processes including wound healing and collagen deposition. Increased LPA activity and activation of the LPA1 receptor have been implicated in pulmonary fibrosis.
Admilparant is therefore being developed as an antifibrotic treatment: rather than simply treating symptoms such as breathlessness or cough, it is intended to interfere with biological processes involved in progressive lung scarring.
If approved, Bristol Myers Squibb says admilparant could potentially become a first-in-class LPA1-targeting treatment for pulmonary fibrosis.
What is idiopathic pulmonary fibrosis?
Idiopathic pulmonary fibrosis is a chronic disease in which lung tissue becomes progressively scarred and stiff. “Idiopathic” means that the underlying cause is unknown.
As fibrosis progresses, the lungs become less effective at transferring oxygen and patients can experience increasing breathlessness, persistent cough, fatigue and declining ability to carry out normal activities.
IPF can progress at very different rates between individuals, but the damage caused by fibrosis is considered irreversible.
Current treatment therefore focuses heavily on slowing further deterioration rather than reversing existing lung scarring.
How does admilparant compare with existing IPF treatments?
Antifibrotic medicines including nintedanib and pirfenidone are established treatments for idiopathic pulmonary fibrosis and can slow the decline in lung function in appropriate patients.
Admilparant uses a different mechanism by selectively targeting LPA1.
That does not yet mean admilparant is better than existing treatments. The initial Phase 3 announcement reported its performance against placebo, not evidence establishing superiority over nintedanib or pirfenidone.
The ALOFT programme has also been designed to allow patients with or without stable background antifibrotic treatment, which may eventually help researchers understand whether admilparant could be used alongside existing therapy.
More detailed Phase 3 results will be needed before its potential place in IPF treatment can be properly assessed.
What did earlier admilparant research show?
The Phase 3 programme followed encouraging results from a randomised Phase 2 study involving separate groups of patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.
In the IPF group, the rate of change in percentage of predicted FVC over 26 weeks was -2.7% with placebo and -1.2% with admilparant 60 mg twice daily.
The estimated treatment difference between the 60 mg dose and placebo was 1.4 percentage points, with a 95% confidence interval ranging from -0.1 to 3.0.
Bristol Myers Squibb has described the result as a 62% relative reduction in the rate of lung-function decline compared with placebo.
The Phase 2 findings supported moving the medicine into the larger Phase 3 ALOFT programme. They should not, however, be substituted for the still-unpublished detailed Phase 3 effect size.
What do we know about admilparant’s safety?
Bristol Myers Squibb reported that admilparant had a favourable safety and tolerability profile in ALOFT-IPF and said discontinuations caused by adverse events were low and similar to placebo at both doses.
However, the full Phase 3 safety dataset has not yet been published.
That makes it important to distinguish the company’s topline safety assessment from a complete evaluation of adverse events once detailed trial data become available.
Earlier Phase 2 research found that treatment discontinuations due to adverse events were similar across the IPF treatment groups. Diarrhoea occurred at similar frequencies with admilparant and placebo, while transient reductions in blood pressure after the first dose were observed and were greater with admilparant.
Full Phase 3 safety results will therefore be an important part of the regulatory and clinical assessment.
Is admilparant approved or available to patients?
No. Admilparant remains an investigational medicine.
A successful Phase 3 trial does not itself constitute regulatory approval. Regulators must review the complete evidence on efficacy, safety, manufacturing and the overall benefit-risk profile before deciding whether a medicine can be marketed.
Bristol Myers Squibb says it will complete its evaluation of the ALOFT-IPF results and engage with health authorities in preparation for planned regulatory submissions.
No approval date or routine patient availability date has yet been announced.
Could admilparant treat other forms of pulmonary fibrosis?
Potentially, but this is also still being studied.
Admilparant is being evaluated in a second Phase 3 trial called ALOFT-PPF involving people with progressive pulmonary fibrosis.
Progressive pulmonary fibrosis can occur in patients with several forms of interstitial lung disease and differs from IPF because an underlying disease or cause may be identifiable.
The ALOFT-PPF trial is fully enrolled, and topline results are expected in early 2027.
A positive result in that study could broaden the potential clinical relevance of LPA1 inhibition beyond idiopathic pulmonary fibrosis, but those results are not yet available.
What does the Phase 3 result mean for patients?
The ALOFT-IPF result moves admilparant substantially closer to possible regulatory review, but it does not change current treatment options today.
The most encouraging finding is that the 60 mg dose achieved a statistically significant effect on lung-function decline in a large, pivotal Phase 3 study after earlier Phase 2 evidence pointed in the same direction.
There are also important unanswered questions. The magnitude of the Phase 3 benefit has not yet been disclosed, the higher 120 mg dose did not achieve statistical significance, detailed secondary outcomes remain unavailable and the complete safety results still need to be evaluated.
The next major milestones will be publication or presentation of the full ALOFT-IPF results and subsequent regulatory submissions.
MediSearcher will update this article when detailed Phase 3 data are released or when regulators announce decisions affecting the availability of admilparant.
Reviewed by: Dr Mattias Hagman, PhD
Editorial review: This article was reviewed for source accuracy, clinical-trial context and consistency with MediSearcher’s editorial standards. Information about the ALOFT-IPF Phase 3 trial, admilparant’s mechanism, previous Phase 2 findings and current treatment status was checked against the trial sponsor’s Phase 3 announcement, published peer-reviewed research, clinical-trial information and established clinical guidance.
Last reviewed: 14 October 2026
Sources and verification
MediSearcher reviewed the following primary and authoritative sources when preparing this article:
- Bristol Myers Squibb: Phase 3 ALOFT-IPF topline results, published 12 October 2026
- American Journal of Respiratory and Critical Care Medicine / PubMed: Phase 2 randomised clinical trial of admilparant in idiopathic and progressive pulmonary fibrosis
- CHEST / PubMed: analysis of disease progression in the Phase 2 admilparant pulmonary fibrosis study
- NICE: idiopathic pulmonary fibrosis diagnosis and management guidance, including established antifibrotic treatment recommendations
MediSearcher provides general information about medicines, clinical research and healthcare. Admilparant is an investigational medicine and is not currently approved for the treatment of idiopathic pulmonary fibrosis. This article does not provide personal medical advice or recommend changing an existing treatment. Patients should discuss treatment decisions with an appropriately qualified healthcare professional.