Product Description
SM04554 is a novel small molecule, topical scalp treatment for AGA targeting the Wnt pathway, a pathway known to regulate hair growth.
Mechanisms of Action: Wnt Activator
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Topical
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Biosplice Therapeutics
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Alopecia Areata
Phase 1: Alopecia
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
ACTRN12615000980538 |
None | P1 |
Completed |
Alopecia |
2015-11-26 |
2024-08-29 |
Treatments |
|
ACTRN12613000974707 |
ACTRN12613000974707 | P1 |
Completed |
Alopecia |
2013-11-14 |
2025-10-23 |
Treatments |
|
NCT02503137 |
SM04554-AGA-04 | P2 |
Completed |
Alopecia Areata |
2016-04-01 |
2021-05-15 |
Primary Endpoints |
|
NCT02275351 |
SM04554-AGA-02 | P2 |
Completed |
Alopecia Areata |
2015-11-01 |
2021-05-15 |
||
NCT03742518 |
SM04554-AGA-05 | P3 |
Completed |
Alopecia Areata |
2020-12-31 |
15% |
2021-05-15 |
Primary Endpoints|Treatments |