Drugs / eRapa
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT06950385 | Jul 2025 → Jul 2030 expected | classic or attenuated familial adenomatous polyposis | Rapamycin Holdings Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-06-29 | Biodexa Pharmaceuticals | Regulatory Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress biodexapharma.com ↗ |
| 2025-11-03 | Biodexa Pharmaceuticals | Regulatory Biodexa Announces Approval of CTA in Europe for Phase 3 Serenta Trial in FAP First European patient expected to be enrolled in 4Q 2025 Addressable US – European Market Put at $7 Billion biodexapharma.com ↗ |
| 2025-07-14 | Biodexa Pharmaceuticals | Regulatory Biodexa Announces Filing of CTA in Europe for Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP) biodexapharma.com ↗ |
| 2025-05-12 | Biodexa Pharmaceuticals | Regulatory Biodexa Receives Orphan Drug Designation in Europe for eRapa in FAP biodexapharma.com ↗
This Orphan Drug Designation is another important step as we move our FAP program forward into a registrational Phase 3 study. |
| 2025-02-10 | Biodexa Pharmaceuticals | Regulatory Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis biodexapharma.com ↗
the US Food and Drug Administration (“FDA”) has granted Fast Track designation for eRapa, a proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP). |
| 2024-06-24 | Biodexa Pharmaceuticals | Results Biodexa Announces Positive Phase 2 Clinical Trial Results of eRapa™ at 12 months in Familial Adenomatous Polyposis (FAP) biodexapharma.com ↗
Biodexa Announces Positive Phase 2 Clinical Trial Results of eRapa™ at 12 months in Familial Adenomatous Polyposis (FAP) |
| 2024-06-10 | Biodexa Pharmaceuticals | Results Twelve month Phase 2 Clinical Trial Results of eRapa™ in Familial Adenomatous Polyposis (FAP) to be Presented at Prestigious Biennial InSIGHT 2024 Meeting in Barcelona biodexapharma.com ↗
In summary, eRapa appeared safe and well-tolerated with a significant 24% reduction in the total polyp burden at six months compared with baseline (p=0.04) and an overall 83% non-progression rate. |
| 2024-05-21 | Biodexa Pharmaceuticals | Results Positive Statistically Significant Phase 2 Clinical Trial Results of Biodexa’s Newly-licensed eRapa™ in Familial Adenomatous Polyposis (FAP) Scheduled for Presentation at the 2024 Digestive Disease Week Annual Meeting biodexapharma.com ↗
In summary, eRapa appeared safe and well-tolerated with a significant 24% reduction in the total polyp burden at six months compared with baseline (p=0.04) and an overall 83% non-progression rate. |
All press releases naming this drug 15 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | eRapa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06950385 ↗ |
| Known as | rapamycin | “eRapa (encapsulated rapamycin)” NCT06950385 ↗ |
| Route | Oral | “0.5 mg capsules for oral use” NCT06950385 ↗ |