Drugs / Orellanine
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05287945 | Aug 2023 → Dec 2027 expected | renal cell carcinoma | Oncorena AB | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-03-04 | Oncorena AB | Regulatory Oncorena receives regulatory approval in France and Portugal to initiate the Oncorella-1 clinical study oncorena.se ↗
Oncorena is pleased to announce that French and Portuguese regulatory authorities have granted approval to expand the Company’s Phase I/II clinical study, Oncorella-1 (NCT05287945; ONC001-CL-001), to France and Portugal. |
| 2025-03-18 | Oncorena AB | Regulatory Oncorena receives FDA approval to initiate studies in the US oncorena.se ↗
Oncorena is pleased to announce that the FDA has approved the Company’s IND application to initiate the Phase I/II study Oncorella-1: A Phase 1/2, open label, single arm study on safety, tolerability and anti-tumor efficacy of orellanine treatment in patients with metastatic clear-cell or papillary renal cell carcinoma (NCT05287945, ONC001-CL-001). |
| 2021-03-01 | Oncorena AB | Regulatory Oncorena Receives Approval of First in Patient Trial with Orellanine as a Potential Breakthrough Therapy in Metastatic Renal Cancer Patients oncorena.se ↗
All preclinical activities have been completed and the Swedish Medical Products Agency has approved Oncorena´s first clinical trial in patients with metastatic renal cancer on dialysis. |
All press releases naming this drug 7 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Orellanine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05287945 ↗ |
| Known as | ONC175 | “Participants receive orellanine (ONC175) as a 30 minute intravenous infusion once during each 28 day treatment cycle.” NCT05287945 ↗ |
| Modality | Small molecule | — CHEMBL2152646 ↗ |
| Route | Intravenous | “Orellanine administered intravenously” NCT05287945 ↗ |