Drugs / Vipoglanstat
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04617509 | Mar → May 2020 | — | Gesynta Pharma AB | Completed | No outcome recorded |
| Phase 1 | NCT04036227 | Jul → Dec 2019 | — | Gesynta Pharma AB | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT07260669 | Oct 2025 → Jun 2027 expected | endometriosis | Gesynta Pharma AB | Recruiting | No outcome recorded |
| Phase 2 | NCT04744207 | Dec 2020 → Jun 2022 | systemic sclerosis | Gesynta Pharma AB | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-09-30 | Gesynta Pharma AB | Regulatory Gesynta Pharma receives UK approval for a Phase 2 trial of vipoglanstat in endometriosis gesynta.se ↗
Gesynta Pharma AB today announced that its clinical trial application for the company's Phase 2 trial of vipoglanstat for the treatment of endometriosis has been approved by the UK authorities. |
| 2022-10-20 | Gesynta Pharma AB | Results Gesynta Pharma prepares Phase II study of GS-248 in endometriosis following ground-breaking data from a preclinical proof-of-concept study gesynta.se ↗
This strategically important decision follows a recent preclinical proof-of-concept study with GS-248 in an advanced model of endometriosis, where disease-modifying properties of the drug candidate were firmly established. |
| 2022-09-09 | Orexo AB | Results Orexo’s partner Gesynta Pharma has announced phase II study results from the OX-MPI (GS-248) project orexo.com ↗
According to Gesynta Pharma, OX-MPI (GS-248) was tolerated well by patients and showed a good safety profile. |
| 2022-09-08 | Gesynta Pharma AB | Results Gesynta Pharma presents results from an exploratory clinical study of its drug candidate GS-248 gesynta.se ↗
GS-248 was well tolerated, exhibited a favorable safety profile, and elicited a potent systemic inhibition of the target enzyme mPGES-1. |
| 2022-04-27 | Gesynta Pharma AB | Regulatory Gesynta Pharma's drug candidate GS-248 granted Orphan Drug Designation in US by the FDA for the treatment of systemic sclerosis gesynta.se ↗
Gesynta Pharma AB today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's drug candidate GS-248 for the treatment of systemic sclerosis. |
| 2022-04-27 | Orexo AB | Regulatory Orexo´s partner Gesynta Pharma granted Orphan Drug Designation by the FDA for OX-MPI (GS-248) for the treatment of systemic sclerosis orexo.com ↗ |
| 2021-06-14 | Gesynta Pharma AB | Regulatory Phase II update: Gesynta Pharma announces significant progress across development program for first-in-class drug candidate GS-248 gesynta.se ↗
Gesynta Pharma AB today announced that an IND (Investigational New Drug Application) has been submitted to the U.S. Food & Drug Administration for its oral drug candidate GS-248 in patients with systemic sclerosis. |
| 2021-06-14 | Orexo AB | Regulatory Orexo’s Partner Gesynta Pharma announces progresses in phase II study of OX-MPI and submits IND with FDA orexo.com ↗ |
| 2020-06-11 | Gesynta Pharma AB | Results Gesynta Pharma reports positive Phase I results with lead candidate GS-248 for microvascular disease at EULAR 2020 gesynta.se ↗
The study demonstrated that GS-248 was safe and well tolerated with a pharmacokinetic profile supporting once daily dosing and with potent and durable effects on relevant anti-inflammatory (PGE2 decrease) and vasoprotective (prostacyclin increase) biomarkers. |
| 2020-05-15 | Gesynta Pharma AB | Results Gesynta Pharma announces positive Phase I results with GS-248 for the treatment of microvascular disease - data to be presented at EULAR congress gesynta.se ↗
In summary, GS-248 was safe and well tolerated with a pharmacokinetic profile supporting once daily dosing and with potent and durable effects on relevant anti-inflammatory and vasoprotective biomarkers. |
| 2020-05-15 | Orexo AB | Results Orexo´s partner Gesynta Pharma announces positive results from phase 1 study for OX-MPI orexo.com ↗
Orexo´s partner, Gesynta Pharma, today announces positive phase I results for OX-MPI (GS-248). |
All press releases naming this drug 17 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vipoglanstat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07260669 ↗ |
| Known as | GS 248 | “receive either GS 248 or placebo in a 3:1 ratio” NCT04036227 ↗ |
| Modality | Small molecule | — CHEMBL3694493 ↗ |
| Route | Oral | “GS-248 oral solution” NCT04036227 ↗ |