Drugs

Rexaceract

Rexaceract (GT-02287) is a small molecule developed by Gain Therapeutics for Parkinson's disease. The next event is Regulatory submission for Rexaceract, expected Q4 2026 (source).

Also known as
GT-02287
Company
How it works
Allosteric glucocerebrosidase stabilizer
Approved
Not approved in any market we track

Development by disease

Parkinson's diseasePhase 1b

Upcoming events

Estimated timing · a month, quarter, half-year or year-end the company gave

Expected in Q4 2026

Expected in Q1 2027

Past results and milestones

  • Oct 1, 2026
    Phase 1b nine-month extension readout shows motor stabilization (MDS-UPDRS) and GluSph biomarker reduction over 12 months of rexaceract dosing in 12 evaluable participants, with favorable safety profile and no new adverse signals. Data support disease-modifying potential and progression to Phase 2. Source
  • Jun 29, 2026
    FDA authorized GT-02287 IND application on June 29, 2026, enabling Phase 2 clinical trial initiation. Source
  • May 26, 2026
    Phase 1b extension interim data released showing significant biomarker improvement (81% GluSph reduction in high-baseline participants), stable MDS-UPDRS scores, and durability through Day 150; all 16 participants remain enrolled. Source
  • Mar 26, 2026
    IND submission to FDA completed; company continues FDA engagement for Phase 2 development clearance expected in 2Q26. Source
  • Feb 3, 2026
    90-day dosing completed in Q4 2025 with statistically significant biomarker evidence of disease-modifying effect and improvement in MDS-UPDRS scores Source
  • Oct 14, 2025
    First biomarker analysis from Phase 1b GT-02287 presented at KOL event with expert input on target engagement and GCase stabilization mechanism to inform Phase 2 design. Source
  • Oct 6, 2025
    Phase 1b 90-day biomarker readout completed with positive safety and efficacy signals. GT-02287 was safe and well-tolerated with no serious adverse events; several participants showed improvement in UPDRS Part II and III scores by Day 90, suggesting disease-slowing effect. Source
The investment thesis, what each upcoming event depends on and the competitive landscape are on the Gain Therapeutics page. Upcoming FDA decisions · All drugs