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bempikibart

Phase 2

Alopecia Areata | Small molecule | Dermatology |Q32 Bio Inc.|Last Updated: May 8, 2026

Target and mechanism

Molecular targetIL-7Rα
Target classProtein
ModalitySmall molecule

Also known as bempikibart (ADX-914)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment75

FDA Designations

FAST_TRACK

Clinical trial landscape

bempikibart · 1 trial · 1 indication

Phase 2 1
NCT06018428A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)Alopecia Areata
ACTIVE NOT_RECRUITING75 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)
Alopecia AreataUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: Mean relative percent change in SALT score
24 Weeks

Part A: Mean relative percent change in SALT score at 24 weeks compared with baseline

Part B: Mean percent change from baseline in SALT score
36 weeks

Part B: Mean percent change from baseline in SALT score at Week 36

Secondary Endpoints

Part A: Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18.
18 Weeks
Part A: Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir.
24 Weeks
Part A: Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24.
24 Weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Experimental: bempikibart (ADX-914)EXPERIMENTAL200mg dose of bempikibart (ADX-914) administered via injection under the skin

Interventions

NameTypeDescription
bempikibart (ADX-914)DRUGSubcutaneous administration of bempikibart (ADX-914)
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites33

Key Inclusion Criteria: 1. Adult men and women, aged 18 to 75 years, inclusive, at the time of informed consent. 2. Clinical diagnosis of severe to very severe alopecia areata, defined as the presence of ≥50% total scalp hair loss at screening and baseline as measured by the SALT score. Key Exclus...

Countries:United StatesCanada
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Frequently asked questions about bempikibart

What is bempikibart used for?

Bempikibart is an investigational small molecule being developed for the treatment of severe alopecia areata, a dermatologic condition. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in a proof-of-concept trial for this indication.

What does bempikibart target?

Bempikibart targets IL-7Rα, a protein involved in immune signaling. By targeting this receptor, the drug is designed to modulate immune responses relevant to alopecia areata. It is a small molecule therapeutic being investigated for its potential to treat severe forms of this condition.

Who makes bempikibart?

Bempikibart is being developed by Q32 Bio Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with severe alopecia areata. Q32 Bio is advancing this asset through Phase 2 clinical development.

What phase is bempikibart in?

Bempikibart is currently in Phase 2 clinical development. It is being studied in a Phase 2a proof-of-concept trial for severe alopecia areata. The drug has received Fast Track designation from the FDA, but it remains investigational and is not yet approved for any use.

What clinical trials is bempikibart in?

Bempikibart is being evaluated in a single active clinical trial, NCT06018428, titled 'A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)'. This trial is enrolling 75 participants in the United States and Canada and is currently active but not recruiting.

Is bempikibart the same as ADX-914?

Yes, bempikibart is also known as ADX-914. The drug is referred to by both names in clinical research, with the Phase 2a trial using the name 'Bempikibart (ADX-914)' in its title. This alternative name may appear in scientific literature and trial registries.