Drugs / Zidesamtinib
Zidesamtinib
also known as
NVL-520 · NU-0002362 · NU-0002362-006 · NU-0002362-009 · NU-2362-010 · NU-520 · NUV-520
Small molecule targets ROS1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | JIDEYTRO | — | 2026-07-22 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05118789 | Jan 2022 → Dec 2027 expected | metastatic neoplasm | Nuvalent Inc. | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06797362 | — | non-small cell lung carcinoma | Nuvalent Inc. | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | GlaxoSmithKline | Results GSK presents positive registrational data to potentially expand Jideytro (zidesamtinib) to first-line ROS1-positive non-small cell lung cancer gsk.com ↗
Progression-free survival (PFS) was 90% at 12 months. |
| 2026-07-22 | GlaxoSmithKline | Regulatory Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer gsk.com ↗ |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | GlaxoSmithKline | GSK presents positive registrational data to potentially expand Jideytro (zidesamtinib) to first-line ROS1-positive non-small cell lung cancer gsk.com ↗ |
| 2026-07-22 | GlaxoSmithKline | Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer gsk.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zidesamtinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05118789 ↗ |
| Known as | NU-0002362 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314497 ↗ |
| Known as | NU-0002362-006 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314497 ↗ |
| Known as | NU-0002362-009 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314497 ↗ |
| Known as | NU-2362-010 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314497 ↗ |
| Known as | NU-520 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314497 ↗ |
| Known as | NUV-520 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314497 ↗ |
| Known as | NVL-520 | “Oral tablet of zidesamtinib (NVL-520)” NCT05118789 ↗ |
| Action | Inhibit | “ROS1 inhibitor” NCT05118789 ↗ |
| Modality | Small molecule | — CHEMBL5314497 ↗ |
| Route | Oral | “Oral tablet of zidesamtinib (NVL-520)” NCT05118789 ↗ |
| Target | ROS1 | “ROS1 inhibitor” NCT05118789 ↗ |