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HCW9302

Phase 1

Alopecia Areata(AA) | Small molecule | Dermatology |HCW Biologics Inc.|Last Updated: Sep 15, 2026

Target and mechanism

Molecular targetIL-2
ModalitySmall molecule

Also known as HCW9302, an IL-2 fusion protein

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

HCW9302 · 1 trial · 1 indication

Phase 1 1
NCT07049328HCW9302 (Interleukin-2 Fusion Protein) for Alopecia AreataAlopecia Areata(AA)
RECRUITING30 Analytics
PHASE1RECRUITING
HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata
Alopecia Areata(AA)Unlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment-Emergent Adverse Events (TEAEs) in Subjects Receiving HCW9302 Monotherapy
9 Weeks

Evaluate the safety profile of HCW9302 monotherapy in subjects with Alopecia Areata (AA), based on the incidence, type, and severity of adverse events (AEs) classified according to MedDRA.

Designate the recommended Phase 2 dose level (RP2D) for Phase 2 study of HCW9302 in subjects with AA
9 Weeks

Secondary Endpoints

Determine the percent change from baseline of Severity of Alopecia Tool (SALT) score (0-100) at Day 29 and Week 9 in AA subjects receiving HCW9302
9 Weeks
Determine the change from baseline of Alopecia Areata-Investigator Global Assessment (AA-IGA) score at Day 29 and Week 9 in AA subjects receiving HCW9302
9 Weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Study of HCW9302, an IL-2 fusion protein, for alopecia areataEXPERIMENTALSingle dose subcutaneous injection of HCW9302.

Interventions

NameTypeDescription
HCW9302, an IL-2 fusion proteinDRUGInjection
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Adult women who are 18 to 70 years of age, or adult males who are 18 to 60 years of age at the time of informed consent. 2. Clinical diagnosis of Alopecia Areata (AA) (including ophiasis, totalis or universalis forms) at Screening. 3. Negative serum pregnancy test within 14 d...

Countries:United States
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Recent Changes (Last 90 Days)

LOWSep 16, 2026NCT07049328lastUpdatePostDate: changed
LOWSep 16, 2026NCT07049328lastUpdatePostDate: changed
LOWSep 16, 2026NCT07049328lastUpdatePostDate: changed
LOWSep 16, 2026NCT07049328lastUpdatePostDate: changed
MEDIUMAug 24, 2026NCT07049328primaryCompletionDate: changed
MEDIUMAug 24, 2026NCT07049328primaryCompletionDate: changed

Frequently asked questions about HCW9302

What is HCW9302?

HCW9302 is an investigational interleukin-2 (IL-2) fusion protein being developed by HCW Biologics Inc. for the treatment of alopecia areata, an autoimmune condition that causes hair loss. It is currently in Phase 1 clinical development and has not been approved by the FDA.

What is HCW9302 used for in alopecia areata?

HCW9302 is being studied as a treatment for alopecia areata (AA), an autoimmune skin condition that causes hair loss. The Phase 1 trial is enrolling adults 18 years and older with alopecia areata in the United States. It is investigational and has not been approved for any indication.

What does HCW9302 target?

HCW9302 targets interleukin-2, or IL-2. It is an IL-2 fusion protein designed to engage the IL-2 pathway, which plays a role in regulating immune cell activity relevant to autoimmune conditions such as alopecia areata. The drug is in Phase 1 development.

Who makes HCW9302?

HCW9302 is developed by HCW Biologics Inc., which trades on the Nasdaq under the ticker HCWB. The company is sponsoring the Phase 1 clinical trial of the IL-2 fusion protein in alopecia areata.

What phase is HCW9302 in?

HCW9302 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The single Phase 1 trial is currently recruiting participants with alopecia areata, with a planned enrollment of 30 patients.

What clinical trials is HCW9302 in?

HCW9302 is being evaluated in one Phase 1 clinical trial, NCT07049328, titled "HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata." The trial is recruiting 30 participants aged 18 years and older in the United States. It is an uncontrolled, non-randomized study.

Is HCW9302 the same as an IL-2 fusion protein?

Yes. HCW9302 is also referred to as an IL-2 fusion protein, reflecting its structure as a fusion protein that targets interleukin-2. Searches for either name refer to the same investigational asset developed by HCW Biologics Inc. for alopecia areata.