Drugs / OPD5
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed plasma cell myeloma 1 milestone | |||||
| Filed | US (FDA) | — | plasma cell myeloma | 2020-10-19 | “the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), for OPD5” oncopeptides.com ↗ |
| Clinical hold Indication not stated 1 milestone | |||||
| Clinical hold | US (FDA) | — | — | 2021-07-28 | “FDA has lifted the clinical hold previously placed on Oncopeptides’ next-generation drug OPD5” oncopeptides.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04918511 | May 2021 → Mar 2024 | plasma cell myeloma | Oncopeptides AB | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-05-19 | Oncopeptides AB | Regulatory Oncopeptides receives formal approval from Norwegian authorities to initiate Window-of-Opportunity study in glioblastoma oncopeptides.com ↗
The approval, which was received earlier than the company had expected, means that the planned study is now approved to commence. |
| 2025-04-01 | Oncopeptides AB | Regulatory U.S. Food and Drug Administration removes clinical hold of Oncopeptides’ pipeline drug OPD5 oncopeptides.com ↗
Stockholm – April 1, 2025 – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, today announces the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on Oncopeptides’ next-gen drug OPD5. |
| 2020-10-19 | Oncopeptides AB | Regulatory Oncopeptides AB: Oncopeptides has submitted an Investigational New Drug application to FDA for the second drug candidate from the PDC platform oncopeptides.com ↗
Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), for OPD5 – a second drug candidate based on the proprietary Peptide Drug Conjugate platform (PDC). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-19 | Oncopeptides AB | Oncopeptides receives formal approval from Norwegian authorities to initiate Window-of-Opportunity study in glioblastoma oncopeptides.com ↗ |
| 2025-04-01 | Oncopeptides AB | U.S. Food and Drug Administration removes clinical hold of Oncopeptides’ pipeline drug OPD5 oncopeptides.com ↗ |
| 2020-10-19 | Oncopeptides AB | Oncopeptides AB: Oncopeptides has submitted an Investigational New Drug application to FDA for the second drug candidate from the PDC platform oncopeptides.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OPD5 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04918511 ↗ |
| Route | Intravenous | “OPD5 solution for i.v. infusion” NCT04918511 ↗ |