Drugs / ASENGEPRAST
ASENGEPRAST
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT04647890 | Jul 2021 → Oct 2022 | diffuse scleroderma | Certa Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2024-07-22 | Certa Therapeutics | Regulatory Certa Therapeutics Receives EU Orphan Designation for FT011, a GPR68 Inhibitor Being Developed as an Anti-Fibrotic Treatment for Systemic Sclerosis certatherapeutics.com ↗
Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for its lead drug candidate, FT011, as a potential treatment of Systemic Sclerosis (SSc). |
| 2024-02-19 | Certa Therapeutics | Regulatory Certa Therapeutics’ FT011 Granted US FDA Fast Track for the Treatment of Systemic Sclerosis certatherapeutics.com ↗
Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma), |
| 2023-11-15 | Certa Therapeutics | Results Certa Therapeutics presents positive data from a Phase 2 clinical study highlighting the potential benefit of FT011 as a novel treatment for scleroderma certatherapeutics.com ↗
FT011 was safe and well tolerated; clinically meaningful improvement in patients with scleroderma over placebo in both treatment arms after 12 weeks |
| 2023-11-15 | Certa Therapeutics | Results ABSTRACT: FT011 for the treatment of Systemic Sclerosis. Results from a Phase II study. certatherapeutics.com ↗
ABSTRACT: FT011 for the treatment of Systemic Sclerosis. Results from a Phase II study. |
| 2023-10-24 | Certa Therapeutics | Regulatory Certa Therapeutics’ FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic Sclerosis certatherapeutics.com ↗
Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for its investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma). |
| 2023-03-17 | Certa Therapeutics | Results Listen to Professor Darren Kelly’s interview with Dr Moira Gunn for her TechNation Radio Podcast certatherapeutics.com ↗
Data from the trial demonstrates clinically meaningful improvements for more than 60 per cent of patients with Scleroderma after 12 weeks of treatment and showed it to be safe and well tolerated in this patient population. |
| 2023-02-06 | Certa Therapeutics | Results Ground-breaking results in Phase 2 scleroderma study by Certa Therapeutics demonstrates improvement in more than 60% of patients certatherapeutics.com ↗
Certa Therapeutics (Certa) today announces ground-breaking clinical trial data for FT011, its novel therapy for the treatment of serious inflammatory and fibrotic diseases. |
| 2022-11-04 | Certa Therapeutics | Results Certa Therapeutics’ investigational drug FT011 delivers breakthrough results as a potential novel treatment for serious inflammatory and fibrotic diseases certatherapeutics.com ↗
The research demonstrated that treatment with FT011 results in a remarkable reversal in the activation of genetic markers associated with fibrosis |
| 2021-02-23 | Certa Therapeutics | Regulatory Certa Therapeutics receives FDA IND approval to open Phase II clinical trial for its lead candidate FT011 certatherapeutics.com ↗
Certa Therapeutics, a biotechnology company focused on improving lives by developing innovative precision treatments for inflammatory and fibrotic diseases, has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) approval to commence a Phase II clinical trial evaluating FT011 as an anti-fibrotic drug for the treatment of systemic sclerosis (SSc). |
| 2021-01-21 | Certa Therapeutics | Regulatory Certa Therapeutics receives ethics approvals for the Phase II clinical trial of FT011 certatherapeutics.com ↗
Certa Therapeutics, a biotechnology company focused on improving lives by developing innovative precision treatments for inflammatory and fibrotic diseases, announce that they have received ethics approvals, to commence the phase II clinical trial studying FT011 as an anti-fibrotic drug for the treatment of systemic sclerosis (SSc). |
| 2020-05-03 | Certa Therapeutics | Results Certa Therapeutics presents new research at ARVO conference in Baltimore certatherapeutics.com ↗
The findings demonstrate that oral administration of FT011 to patients undergoing GFS results in safe and robust exposure levels of the drug in the aqueous humor (AH) and Tenon’s capsule (TC). |
All press releases naming this drug 14 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ASENGEPRAST | ChEMBL registry synonym — accepted as the source's own label CHEMBL1075834 ↗ |
| Known as | FT-11 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1075834 ↗ |
| Known as | FT011 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04647890 ↗ |
| Known as | Shp-627 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1075834 ↗ |
| Modality | Small molecule | — CHEMBL1075834 ↗ |
| Route | Oral | “Oral FT011” NCT04647890 ↗ |