Drugs / GT-02287
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | Parkinson disease | 2026-03-12 | “The Company submitted an IND to conduct a placebo-controlled, dose-range-finding Phase 2 clinical trial of GT-02287 in the United States.” gaintherapeutics.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06732180 | Feb → Nov 2025 overdue | Parkinson disease | Gain Therapeutics, Inc. | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT07280299 Comparator | May 2026 → Jun 2028 expected | Parkinson disease | Gain Therapeutics, Inc. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2026-06-29 | Gain Therapeutics, Inc. | Regulatory Gain Therapeutics Receives FDA Clearance of IND to Advance GT-02287 into Phase 2 Clinical Development for Parkinson’s Disease gaintherapeutics.com ↗ |
| 2026-05-26 | Gain Therapeutics, Inc. | Results Gain Therapeutics Presents Positive Interim Data from Phase 1b Clinical Study of GT-02287 at 3rd International GBA1 Meeting 2026 gaintherapeutics.com ↗
The oral presentation outlined new clinical data from the Phase 1b study of GT-02287 further supporting disease-modifying potential in both idiopathic and GBA1 Parkinson’s disease (PD). |
| 2026-03-18 | Gain Therapeutics, Inc. | Results Gain Therapeutics Presents Additional Clinical and Biomarker Data from Phase 1b Clinical Study of GT-02287 and Preclinical Data from Novel Chemical Series at AD/PD 2026 gaintherapeutics.com ↗
The oral presentation outlined new clinical and biomarker data from the Phase 1b clinical study of GT-02287 further supporting disease-modifying potential in both idiopathic and GBA1 Parkinson’s disease. |
| 2026-01-06 | Gain Therapeutics, Inc. | Results Gain Therapeutics Announces Positive Results in Key Exploratory Endpoint from its Phase 1b Clinical Study of GT-02287 in People with Parkinson’s Disease gaintherapeutics.com ↗
All individuals with elevated levels of glucosylsphingosine (GluSph) in the CSF displayed large decreases back towards levels observed in healthy individuals after 90 days of treatment with GT-02287. |
| 2025-11-30 | Gain Therapeutics, Inc. | Results Gain Therapeutics Highlights Biomarker Evidence Supporting Disease-Modifying Potential of GT-02287 gaintherapeutics.com ↗
In participants with elevated baseline levels of glucosylsphingosine (GluSph) in cerebrospinal fluid (CSF) at baseline, GluSph decreased by an average of 81% after 90 days of treatment with GT-02287. |
| 2025-05-12 | Gain Therapeutics, Inc. | Results Gain Therapeutics Presents Preclinical Data at IAPRD 2025 30th World Congress on Parkinson’s Disease and Related Disorders gaintherapeutics.com ↗
The poster outlined new evidence supporting GT-02287’s ability to provide a broader neuroprotective effect and potential as a disease-modifying therapy for Parkinson’s disease. |
| 2025-04-10 | Gain Therapeutics, Inc. | Results Gain Therapeutics Presents Additional Preclinical Data and Design of Phase 1b Clinical Study of GT-02287 at AD/PD 2025 and Provides Enrollment Update gaintherapeutics.com ↗
The oral presentation outlined new evidence further supporting the disease-modifying activity of GT-02287 in preclinical models of both GBA1 and idiopathic Parkinson’s disease (PD). |
| 2024-12-31 | Gain Therapeutics, Inc. | Regulatory Gain Therapeutics Receives Australian Approval of Phase 1b Dosing Extension and Reports Positive Independent Data Monitoring Committee Recommendation gaintherapeutics.com ↗ |
| 2024-12-31 | Gain Therapeutics, Inc. | Results Gain Therapeutics Presents Preclinical GT-02287 Data at Neuroscience 2025 gaintherapeutics.com ↗
GT-02287 reduces mitochondrial stress and enhances neuronal survival in MPP+ treated rat dopaminergic neurons |
| 2024-12-31 | Gain Therapeutics, Inc. | Results Gain Therapeutics Presents Initial Data from Phase 1b Clinical Study of GT-02287 in Parkinson’s Patients at International Congress of Parkinson’s Disease and Movement Disorders® gaintherapeutics.com ↗
GT-02287 was generally well tolerated, with no treatment-emergent serious adverse events observed. |
| 2024-07-09 | Gain Therapeutics, Inc. | Results Gain Therapeutics Announces the Completion of Dosing in the Multiple Ascending Dose (MAD) of the Phase 1 Study of GT-02287, a Novel Small Molecule Therapy for Parkinson’s Disease gaintherapeutics.com ↗
No discontinuations or serious adverse events were reported. |
| 2024-06-27 | Gain Therapeutics, Inc. | Results Gain Therapeutics Presents GT-02287 Data at Federation of European Neuroscience Societies (FENS) Forum 2024 Demonstrating Improvements in Cognitive Performance in a Preclinical Model of GBA1 Parkinson’s disease gaintherapeutics.com ↗
The poster describes improvement in cognitive performance and activities of daily living associated with administration of GT-02287 the Company’s lead novel allosteric therapeutic candidate in a mouse model of GBA1-Parkinson’s disease (GBA1-PD). |
| 2024-04-24 | Gain Therapeutics, Inc. | Results Gain Therapeutics Announces Positive Results from the Single Ascending Dose (SAD) Part of the Phase 1 Clinical Trial of GT-02287, a Novel GCase-Targeting Small Molecule Therapy for GBA1 Parkinson’s Disease gaintherapeutics.com ↗
GT-02287 was generally well tolerated up to and including the highest planned dose level, and there were no serious adverse events. |
| 2024-03-05 | Gain Therapeutics, Inc. | Results Gain Therapeutics Presents Data at the AD/PD™ 2024 Conference Demonstrating the Mechanism of Action of GT-02287, its Clinical Stage GCase Regulator for the Treatment of Parkinson’s Disease gaintherapeutics.com ↗
Data support the ability of GT-02287 to prevent several steps in the disease cascade resulting from GCase misfolding and dysfunction |
| 2023-12-31 | Gain Therapeutics, Inc. | Results Gain Therapeutics Presents Preclinical GT-02287 Data at Neuroscience 2024 gaintherapeutics.com ↗
Another presentation for GT-02287 yesterday described its association with improved mitochondrial function and neuroprotection in GBA1-Parkinson’s disease models. |
| 2023-12-31 | Gain Therapeutics, Inc. | Results Gain Therapeutics Presents Phase 1 GT-02287 Data at International Congress of Parkinson’s Disease and Movement Disorders Demonstrating Increase in GCase Activity in Healthy Volunteers gaintherapeutics.com ↗
The poster and oral platform presentation summarize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single- and multiple-ascending doses of GT-02287, the Company’s clinical stage lead drug candidate, in a Phase 1 first-in-human study in healthy volunteers. |
| 2023-12-31 | Gain Therapeutics, Inc. | Regulatory Gain Therapeutics Initiates Phase 1b Clinical Trial of Lead Candidate GT-02287 in People with GBA1 and Idiopathic Parkinson’s Disease gaintherapeutics.com ↗ |
| 2023-12-31 | Gain Therapeutics, Inc. | Results Gain Therapeutics Announces Positive Topline Results from the Phase 1 Clinical Trial of GT-02287, a Novel GCase-Targeting Small Molecule Therapy for Parkinson’s Disease gaintherapeutics.com ↗
Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, announces positive results from the Phase 1 study conducted to evaluate the safety, tolerability and pharmacokinetics of GT-02287. |
| 2023-06-30 | Gain Therapeutics, Inc. | Regulatory Gain Therapeutics Announces Second Quarter 2023 Financial Results and Business Update gaintherapeutics.com ↗ |
| 2023-03-23 | Gain Therapeutics, Inc. | Results Gain Therapeutics’ GT-02287 Completely Restores Motor Function in Mouse Models of Parkinson’s Disease gaintherapeutics.com ↗
Gain Therapeutics, Inc., (Nasdaq: GANX), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, announces preclinical data demonstrating that its clinical-stage GCase regulator GT-02287 provided neuroprotection and restored motor function in Parkinson’s disease models following delayed administration. |
| 2023-03-23 | Gain Therapeutics, Inc. | Regulatory Gain Therapeutics Receives Approval to Commence Phase 1 Clinical Study of GT-02287 from the Human Research Ethics Committee (HREC) in Australia gaintherapeutics.com ↗
today announced that the Company has received approval from the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate a Phase 1 clinical study of its lead drug candidate GT-02287 in development for GBA1-Parkinson’s disease (GBA1-PD). |
| 2023-03-23 | Gain Therapeutics, Inc. | Results Gain Therapeutics Presents New Preclinical Data Demonstrating a Reduction of Plasma Neurodegeneration Biomarker NfL after Administration of its Drug Candidate GT-02287 in GBA1 Parkinson’s Disease Model gaintherapeutics.com ↗
Treatment with GT-02287 also restored glucocerebrosidase (GCase) enzymatic function, reduced aggregated α-synuclein, neuroinflammation and neuronal death, increased dopamine levels and improved motor function |
| 2022-09-17 | Gain Therapeutics, Inc. | Results Gain Therapeutics Presents New Preclinical Data Demonstrating Potential Disease Modifying Benefits of its Novel Brain Penetrant Small Molecule Candidate GT-02287 in Two Preclinical Models of Parkinson’s Disease gaintherapeutics.com ↗
The results from these latest in vitro and in vivo studies are consistent with previous data presented by the Company and demonstrate statistically significant, dose-dependent effects of GT-02287, the Company’s lead compound for the treatment of Parkinson’s disease. |
| 2022-05-06 | Gain Therapeutics, Inc. | Results Gain Therapeutics Presents Positive Preclinical Data on its Small Molecule Lead Compound in GBA1 Parkinson’s Disease at XXVII IAPRD World Congress gaintherapeutics.com ↗
today announced that it presented positive pre-clinical data from its GBA Parkinson’s Disease (PD) program. |
| 2022-04-12 | Gain Therapeutics, Inc. | Results Gain Therapeutics Presents Positive Data on its Small Molecule Lead Compound in GBA1 Parkinson’s Disease at the 2022 Synuclein Meeting gaintherapeutics.com ↗
The data show that the the lead compound GT-02287 increases the levels and activity of the beta-glucocerebrosidase (GCase) protein, improves lysosomal health, corrects abnormal phenotypes of PD including alpha-synuclein, and most importantly improves neuronal network connections and neuron survival. |
All press releases naming this drug 36 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GT-02287 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06732180 ↗ |
| Route | Oral | “to be administered orally once a day for 90 days” NCT06732180 ↗ |