NCT07618195 EPI-001(Epi Biotech) Androgenetic Alopecia Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07618195 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 7 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07618195 is a hot trial to watch
Androgenetic Alopecia is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07618195 is notable because it evaluates EPI-001(Epi Biotech) in a Phase 1/2 design sponsored by Epi Biotech Co., Ltd.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07618195 |
| Official title | Study of EPI-001 in Patients With Androgenetic Alopecia |
| Phase / status | Phase 1/2 / Recruiting |
| Intervention | EPI-001(Epi Biotech) |
| Sponsor | Epi Biotech Co., Ltd. |
| Geography | South Korea |
| Enrollment | [object Object] |
| Primary endpoint | Incidence of Dose-Limiting Toxicities |
| Endpoint time frame | Up to 4 weeks after administration |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This is a Phase I/IIa clinical study to evaluate the safety, tolerability, and preliminary efficacy of EPI-001 in patients with androgenetic alopecia. In the Phase I portion, a traditional 3+3 dose-escalation design will be used to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of EPI-001. Subjects will be followed for up to 24 weeks after administration. In the Phase IIa portion, subjects will be randomized in a 2:1 ratio to receive either EPI-001 or placebo. Safety and efficacy will be evaluated through hair count assessment, hair diameter measurement, clinical photography, investigator assessment, expert panel assessment, and subject self-assessment during a follow-up period of up to 48 weeks.
Allocation is Randomized, masking is Double, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across South Korea shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Incidence of Dose-Limiting Toxicities (Up to 4 weeks after administration)
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: EPI-001(Epi Biotech) is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Epi Biotech Co., Ltd. is resolved to a normalized organization record in South Korea. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07618195 provides a focused lens on Androgenetic Alopecia development. Its value will be determined by whether EPI-001(Epi Biotech) can convert the current Phase 1/2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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