Drugs / FT-002
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05874310 | Feb → Oct 2023 overdue | retinitis pigmentosa | Frontera Therapeutics | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06492850 | Apr 2024 → Aug 2025 overdue | retinitis pigmentosa | Frontera Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-05-11 | Frontera Therapeutics | Results Frontera Therapeutics Presents Positive Top-Line Phase II Data for FT-002 and FT-003 at ARVO 2026 fronteratherapeutics.com ↗
In the ongoing Phase II study, FT-002 demonstrated a favorable safety profile in pediatric participants through nine months of follow-up, with no serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), or treatment-related ocular inflammation reported. |
| 2025-04-22 | Frontera Therapeutics | Results Frontera to Present Innovative Gene Therapy Advances at the 2025 ARVO and ASGCT Annual Meetings fronteratherapeutics.com ↗
Another poster will share 12-month follow-up clinical data for FT-002, an AAV-based gene therapy for X-linked Retinitis Pigmentosa (XLRP), demonstrating its long-term safety |
| 2024-09-22 | Frontera Therapeutics | Regulatory FDA Clears Frontera’s FT-002 for Phase II Clinical Trials in the U.S. fronteratherapeutics.com ↗
Frontera is excited to announce that its gene therapy product, FT-002, has been cleared by the U.S. Food and Drug Administration (FDA) for Phase II clinical trials in the U.S. |
| 2024-05-06 | Frontera Therapeutics | Results Frontera Therapeutics Unveils Preliminary Clinical Results for FT-002 Injection at Retinal Cell and Gene Therapy Innovation Summit 2024 fronteratherapeutics.com ↗
The patients demonstrated favorable safety profiles throughout the one-year follow-up period, with significant improvements observed in retinal sensitivity and visual function among specific dosage cohorts. |
| 2024-01-23 | Frontera Therapeutics | Regulatory Frontera Therapeutics’ FT-002 Achieves Orphan Drug Designation from the U.S. FDA for Inherited Retinal Dystrophies fronteratherapeutics.com ↗
Frontera Therapeutics announces that its pioneering AAV gene therapy product, FT-002, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of Inherited Retinal Dystrophies (IRD) caused by RPGR gene variants. |
| 2023-12-10 | Frontera Therapeutics | Results Preliminary Clinical Study Results of Frontera Therapeutics FT-002 Injection Presented at APVRS Congress fronteratherapeutics.com ↗
The clinical study results showed that no dose-limiting toxicity was observed in XLRP patients after receiving low, medium and high doses of FT-002, and the safety and tolerability were good. |
| 2023-11-06 | Frontera Therapeutics | Regulatory Frontera Therapeutics announces CDE clearance to initiate clinical trial of a First-in-class gene therapy for the treatment of RPGR-associated X-linked Retinitis Pigmentosa fronteratherapeutics.com ↗
We are strongly encouraged by the CDE IND clearance of this First-In-Class drug. |
All press releases naming this drug 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FT-002 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05874310 ↗ |
| Modality | Gene therapy (AAV / viral vector) | “A clinical trial of gene therapy for patients with X-linked retinitis pigmentosa (XLRP).” NCT05874310 ↗ |
| Route | Other | “Intraocular injection of a single low dose of FT-002” NCT05874310 ↗ |