OliX Pharmaceuticals received approval from New Zealand MedSafe for a Phase 1b/2a clinical trial plan for OLX72021, a treatment for androgenetic alopecia.

OliX Pharmaceuticals amended a prior disclosure (May 2, 2025) to add details of New Zealand MedSafe's approval of the clinical trial plan (Phase 2a). A clinical trial evaluating the safety and efficacy of OLX72021, a treatment for androgenetic alopecia, in 158 healthy men is scheduled to run for approximately 30 months in Australia and New Zealand. The company said the probability of final approval for the investigational drug is statistically approximately 10%.

1. 01

   OliX Pharmaceuticals submitted a clinical trial plan approval application to New Zealand MedSafe on September 8, 2026 and received approval notification on October 8, 2026.

2. 02

   The Phase 1b/2a clinical trial will evaluate the safety, efficacy and effects on sexual function of OLX72021 in healthy men with androgenetic alopecia.

3. 03

   The clinical trial will be conducted in 2 countries, Australia and New Zealand, with approval from the Bellberry Australia Human Research Ethics Committee and New Zealand MedSafe.

4. 04

   The probability of final approval for the investigational drug is statistically approximately 10%, and the clinical trial may produce results different from expectations.

An AI model translated the Korean summary of this filing into English; every number is carried over from the Korean original. Reference information, not investment advice.

Key figures

Target number of trial subjects

158 subjects

Clinical trial duration

Approximately 30 months

Expected completion date

November 2, 2027

Trial sites in Australia

Approximately 10 sites

Trial sites in New Zealand

Approximately 4 sites

Filing facts

Filing type

Technology or Regulatory Approval

Report name

[Amended] Material Management Information for Investment Decisions

Filed

Oct 8, 2026

Receipt number

20261008900549