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Admilparant

Phase 3

Undisclosed | Small molecule | Other |Bristol-Myers Squibb Company|Trials Updated: Aug 14, 2026

Admilparant development status

Highest phase Phase 3 (NCT06025578)
Phase scored for BMYPhase 1
Registered trials 16 across 1 sponsor since Feb 2018

Admilparant target and mechanism

ModalitySmall molecule

Also known as BMS-986278

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials7
Total Enrollment5,200

FDA Designations

No designations recorded

Admilparant clinical trials

Admilparant · 7 trials · 8 indications

Phase 3 3Phase 2 1Phase 1 3
NCT07441408Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary FibrosisPulmonary Fibrosis
NOT YET_RECRUITING2,380 Analytics
NCT06025578A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary FibrosisProgressive Pulmonary Fibrosis
ACTIVE NOT_RECRUITING1,057 Analytics
NCT06003426A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis
ACTIVE NOT_RECRUITING1,255 Analytics
PHASE3NOT YET_RECRUITING
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
Pulmonary Fibrosis
NCT074414082,380
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PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
Progressive Pulmonary Fibrosis
NCT060255781,057
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PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
NCT060034261,255
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Study Endpoints

Primary Endpoints

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Up to Week 100
Number of Participants With Serious Adverse Events (SAEs)
Up to Week 100
Number of Participants With AEs leading to Discontinuation
Up to Week 100
Number of Participants With AEs leading to Deaths
Up to Week 100
Number of Participants With Clinically Significant Laboraty Abnormalities
Up to Week 100
Number of Participants With Clinically Significant Electocardiogram (ECG) Abnormalities
Up to Week 100
Number of Participants With Clinically Significant Vital Sign Abnormalities
Up to Week 100
Number of participants that experience spontaneous syncopal events
At approximately 4 weeks

Cohort 1

Absolute change from baseline in forced vital capacity (FVC) measured in mL
At Week 52

Cohort 2

Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in IPF Participants
From baseline (first dose) up to week 26

Percent predicted forced vital capacity (ppFVC) is the percentage of predicted value per participant of forced vital capacity (FVC). FVC is defined as the maximum capacity of air that a participant can exhale after a maximum inspiration as measured by the volume of air exhaled in a spirometer. The data is reported as percent change from baseline in ppFVC. Percent change from baseline is a calculation that expresses the change in a value compared to its initial starting point (baseline) as a percentage, showing how much a value has increased or decreased relative to its original level; it's calculated by subtracting the baseline value from the new value, dividing by the baseline value, and then multiplying by 100%. The percent change in this endpoint was calculated from ppFVC values taken at baseline, which is defined as the measurement of ppFVC taken at first dose, and ppFVC values taken at Week 26. This endpoint reports data for the IPF cohort only as pre-specified in the protocol.

Maximum observed plasma concentration (Cmax)
Up to 13 days
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Up to 13 days
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to 13 days
Maximum observed concentration (Cmax)
Up to Day 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Up to Day 8
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Up to Day 8
Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination
Up to day 5 of each period (Each period is 7 days; 3 periods total)
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986278 and pirfenidone alone or in combinaton
Up to day 5 of each period (Each period is 7 days; 3 periods total)
Area under the plasma concentration-time curve extrapolated to infinity [(AUC(INF)] of BMS-986278 and pirfenidone alone or in combinaton
Up to day 5 of each period (Each period is 7 days; 3 periods total)

Secondary Endpoints

Number of participants who discontinued treatment due to any low BP-related Adverse Events
Up to approximately 3 years
Disease progression
Up to approximately 3 years
Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score
At Week 52 and up to approximately 3 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-986278 ArmEXPERIMENTAL -
BMS-986278 Dose 1EXPERIMENTAL -
BMS-986278 Dose 2EXPERIMENTAL -
BMS-986278 PlaceboPLACEBO_COMPARATOR -
IPF Dose 1 + Post Treatment Follow-up or OTEEXPERIMENTALIPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)
IPF Dose 2 + Post Treatment Follow-up or OTEEXPERIMENTAL -
IPF Placebo + Post Treatment Follow-up or OTEPLACEBO_COMPARATOR -
PF-ILD Dose 1 + Post Treatment Follow-up or OTEEXPERIMENTALPF-ILD (Progressive Fibrotic Interstitial Lung Disease)
PF-ILD Dose 2 + Post Treatment Follow-up or OTEEXPERIMENTAL -
PF-ILD Placebo + Post Treatment Follow-up or OTEPLACEBO_COMPARATOR -
Part 1: Treatment AEXPERIMENTAL -
Part 1: Treatment BEXPERIMENTAL -
Part 2: Treatment CEXPERIMENTAL -
Part 2: Treatment DEXPERIMENTAL -
Group A and CEXPERIMENTAL -
Group B: Period 1EXPERIMENTAL -
Group B: Period 2EXPERIMENTAL -
BMS-986278EXPERIMENTAL -
PirfenidoneEXPERIMENTAL -
BMS-986278 + PirfenidoneEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986278DRUGSpecified dose on specified days
BMS-986278 PlaceboDRUGSpecified dose on specified days
AdmilparantDRUGSpecified dose on specified days
PirfenidoneDRUGcapsule
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Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites275

Inclusion Criteria: \- Participants must have participated in either IM027068 or IM0271015 without discontinuing treatment permanently due to withdrawal of informed consent in either IM027068 or IM0271015. Exclusion Criteria: * Any disease/condition that, in the investigator's judgment, may pose ...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChileChinaColombiaDenmarkFinlandFranceGermanyGreeceIndiaIrelandIsraelItalyJapanMexicoNetherlandsPeruPortugalSouth KoreaSpainTaiwanUnited KingdomAustriaCzechiaHungaryMalaysiaPolandPuerto RicoSwitzerlandTurkey (Türkiye)
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Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT07441408Enrollment: 2277 → 2380
LOWAug 14, 2026NCT07441408Enrollment: 2277 → 2380
LOWJul 28, 2026NCT07441408lastUpdatePostDate: changed
LOWJul 28, 2026NCT07441408lastUpdatePostDate: changed

Frequently asked questions about Admilparant

What is Admilparant?

Admilparant is an investigational small molecule drug being developed by Bristol-Myers Squibb Company. It is in Phase 1 clinical development, and the specific disease or condition it is intended to treat has not been disclosed. It is not described as approved for any use.

Who makes Admilparant?

Admilparant is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sponsor behind the clinical program for this investigational small molecule.

What phase is Admilparant in?

Admilparant is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. Because it remains in early clinical testing, it is investigational and is not described as approved by the FDA for any indication.

What clinical trials is Admilparant in?

Admilparant has been studied in one completed Phase 1 trial, NCT07225647, titled A Study to Assess the Effect of Food on the Drug Levels of Admilparant. That trial enrolled 56 healthy adult participants in the United States and used a controlled, randomized design without double blinding.

What did the Admilparant food effect trial study?

NCT07225647 was a Phase 1 study assessing how food affects the drug levels of Admilparant. It enrolled 56 healthy volunteers aged 18 and older in the United States, was randomized and controlled, and has been completed. It did not use double blinding and did not select participants by biomarker.

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