Drugs / Opdualag
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Opdualag | — | 2022-09-15 | europa.eu ↗ |
| Approved | US (FDA) | OPDUALAG | — | 2022-03-18 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05970497 | Oct 2023 → Jul 2027 expected | cutaneous melanoma | Krystal Biotech, Inc. | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06319196 | Aug 2026 → Feb 2027 expected | cutaneous melanoma, mucosal melanoma | University Health Network, Toronto | Recruiting | No outcome recorded |
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 | Opdualag | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05970497 ↗ |
| Action | Inhibit | “Dual immunotherapy (PD-1 and LAG-3 immune checkpoint inhibitors)” NCT05970497 ↗ |
| Route | Intravenous | “Opdualag vial IV every 4 weeks (Q4W)” NCT06319196 ↗ |