Product Description
Eflornithine administered by injection is used to treat African sleeping sickness, a disease caused by protozoa (tiny one-celled animals). However, eflornithine hydrochloride applied topically as a cream is the first agent known to help slow the rate of excessive hair growth. It is marketed under the brand name Vaniqa® and comes as eflornithine hydrochloride 13.9% cream. Eflornithine works by blocking the enzyme ornithine decarboxylase (ODC) that stimulates hair growth. (Sourced from: https://dermnetnz.org/topics/eflornithine-hydrochloride)
Mechanisms of Action: ODC Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Croatia | Czech | Denmark | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | India | Ireland | Israel | Italy | Jordan | Latvia | Lebanon | Lithuania | Netherlands | New Zealand | Norway | Pakistan | Peru | Poland | Portugal | Romania | Slovakia | Spain | Sweden | Switzerland | Turkey | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Takeda
Company Location: Asia Pacific
Company Founding Year: 1781
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 5
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Astrocytoma
Phase 2: Breast Cancer|Melanoma|Neuroblastoma|Prostate Cancer|Skin Cancer
Phase 1: Glioblastoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05879367 |
OT-21-101 | P1 |
Recruiting |
Astrocytoma|Glioblastoma |
2026-06-30 |
50% |
2025-06-26 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT07287917 |
AMXT1501-103 | P2 |
Recruiting |
Skin Cancer|Melanoma|Breast Cancer |
2028-02-28 |
12% |
2025-12-18 |
Primary Endpoints|Treatments |
NCT06059118 |
J2326 | P2 |
Recruiting |
Prostate Cancer |
2027-01-04 |
12% |
2026-01-15 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT02139397 |
NMTRC010 | P2 |
Completed |
Neuroblastoma |
2024-01-19 |
30% |
2024-04-26 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
2016-000089-45 |
STELLAR Study | P3 |
Completed |
Astrocytoma |
2024-02-27 |
2025-07-09 |
Treatments |