Drugs / Neladalkib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | ALK-altered non-small cell lung cancer | — | “ALK (neladalkib) inhibitors for non-small cell lung cancer (NSCLC), currently under US FDA review for 2026 approvals” gsk.com ↗ “neladalkib (NVL-655) are considered potential best-in-class assets, based on clinical data, and are under FDA review” gsk.com ↗ “neladalkib (NVL-655) for patients with ALK-altered NSCLC, which is currently under FDA review” gsk.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05384626 | Jun 2022 → Dec 2027 expected | metastatic neoplasm | Nuvalent Inc. | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06765109 | Jul 2025 → Dec 2029 expected | non-small cell lung carcinoma | Nuvalent Inc. | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06834074 | — | non-small cell lung carcinoma | Nuvalent Inc. | Available | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Neladalkib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06765109 ↗ |
| Known as | NVL-655 | “A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)” NCT05384626 ↗ |
| Action | Inhibit | “investigational ALK inhibitor” NCT06834074 ↗ |
| Modality | Small molecule | — CHEMBL6068023 ↗ |
| Route | Oral | “Oral Tablet of Neladalkib (NVL-655)” NCT05384626 ↗ |
| Target | ALK | “investigational ALK inhibitor” NCT06834074 ↗ |