Drug · Monoclonal Antibody
Toripalimab
CI-DRUG-00000598Explore in graph →NCIt C131334 CHEMBL4297843 CIViC Approved
Regulatory
Approvals (4)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | Nasopharyngeal Carcinoma | in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) | approved | Oct 27, 2023 | openfda |
| US FDA | — | as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy | approved | Oct 27, 2023 | openfda |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 18 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 186 | 106 | 34 | 325 | 4 | CA, EU, US | Oct 27, 2023 | 2016-08 |
| Malignant Nasopharyngeal Neoplasm | Approved | Phase 3 | 21 | 13 | 6 | 25 | 1 | US | Oct 27, 2023 | Jun 28, 2020 |
| Malignant Breast Neoplasm | Phase4 | Phase 4 | 13 | 10 | 1 | 19 | 0 | — | — | Dec 21, 2018 |
| Malignant Lung Neoplasm | Phase3 | Phase 3 | 19 | 10 | 6 | 37 |
Curated evidence
Clinical evidence (1)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 39255777
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| High1 | ||||||||
| Chemotherapy + Toripalimab | ||||||||
Clinical trials
Trials with this intervention (335)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT07559929 | A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer. | recruiting | Phase 1 / Phase 2 | 200 | Hangzhou DAC Biotechnology Co., Ltd.INDUSTRY | 1 | Sep 24, 2026 | clinicaltrials |
| NCT06088004 | Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 in Advanced Solid Tumors | recruiting | Phase 1 / Phase 2 |