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Drug

Toripalimab

Approved medicine
ClassProgrammed cell death protein 1 antagonistResearchOngoing clinical research
Also known as Loqtorzi, Teriplizumab, Teriprizumab, Terriptylimab+1 more

Loqtorzi, Teriplizumab, Teriprizumab, Terriptylimab, Triprolizumab.

RxNorm2669406ChEMBLCHEMBL4297843ATCL01FF13UNII8JXN261VVA
118
Active clinical trials
Programmed cell death protein 1
Primary target
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: TORIPALIMAB-TPZI (BLA761240)

Regulatory2026-08-31FDA

Perioperative Chemoimmunotherapy With Toripalimab for Sinonasal Cancer

Clinical trial2026-08-31Results expected Q1 2028 · ClinicalTrials.gov

A Phase 1 Study of CHS-114 in Participants With Advanced Solid Tumors

Clinical trial2026-08-12Status changed to Active, not recruiting · ClinicalTrials.gov

Short-Term Fasting Prior to Standard Checkpoint Blockade Using PD-1/PD-L1 Inhibition: A Pilot Safety and Feasibility Study

Clinical trial2026-08-12Primary completion · ClinicalTrials.gov

An Exploratory Study of Personalized Cancer Vaccine (ABO2109) in Adjuvant Therapy of Solid Tumors

Clinical trial2026-08-03Results expected Q2 2028 · ClinicalTrials.gov

Negative Ultraselection of Patients With RAS/BRAF Wild-type Refractory Right-Sided Metastatic Colorectal Cancer Receiving Cetuximab in Combination With Toripalimab and Irinotecan: A Phase II, Single-arm Study

Clinical trial2026-07-30Primary completion · ClinicalTrials.gov

Perioperative Chemotherapy Combined With PD-1 Inhibitor (Toripalimab) for Treatment of Epstein-Barr Virus-associated Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: a Prospective, Multi-center, Phase II Study

Clinical trial2026-07-28Primary completion · ClinicalTrials.gov

A Randomized Phase 2 Study of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma

Clinical trial2026-07-15Results expected Q3 2027 · ClinicalTrials.gov

Neoadjuvant RC48 Plus Gemcitabine for HER2 1~3+ MIBC: A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Study (GUARD-02)

Clinical trial2026-07-09Results expected Q3 2028 · ClinicalTrials.gov

Label change: TORIPALIMAB-TPZI (BLA761240)

Regulatory2024-10-30FDA

Approval: Loqtorzi (EMA)

Regulatory2024-09-19EMA

Label change: TORIPALIMAB-TPZI (BLA761240)

Regulatory2024-04-22FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Toripalimab
Aliases & brands
LoqtorziTeriplizumabTeriprizumabTerriptylimabTriprolizumab
RxNorm CUI
2669406
ChEMBL ID
CHEMBL4297843
ATC codes
L01FF13
UNII
8JXN261VVA
Primary mechanism
Programmed cell death protein 1 antagonist
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Programmed cell death protein 1
PDCD1 · Q15116
ANTAGONISTProgrammed cell death protein 1 antagonist

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2023-10-27 → 2024-09-19)
Earliest approval
2023-10-27
Latest approval
2024-09-19
Authorities
FDA · EMA
Total events
5
fdaU.S. Food and Drug Administration· 4 events
2026-08-31Label change
Label change: TORIPALIMAB-TPZI (BLA761240)
Evidence ↗
2024-10-30Label change
Label change: TORIPALIMAB-TPZI (BLA761240)
Evidence ↗
2024-04-22Label change
Label change: TORIPALIMAB-TPZI (BLA761240)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2024-09-19ApprovalMulti-authority
Approval: Loqtorzi (EMA)
Indication: Loqtorzi, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or… Show full indication

Loqtorzi, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma. Loqtorzi, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

199 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
199
registered trials across all phases
LATEST COMPLETION 2026
118
Active studies
104
Recruiting
30
Late-stage (III+)
14
Completed
67
Discontinued
PHASE DISTRIBUTIONn = 199
Early Phase 12Phase 116Phase 1 / 229Phase 2122Phase 2 / 37Phase 317Phase N / A6

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Adaptive Immunotherapy for Locoregional Nasopharyngeal Carcinoma: a Randomized, Controlled, Multicenter, Phase 3 Clinical Trial

RecruitingPH IIISun Yat-sen Universityn=8022033

Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma: a Prospecitve, Parallel, Multicenter, Phase III, Randomized Clinical Trial

RecruitingPH IIISun Yat-sen Universityn=2182033

An Open-label, Multicenter, Randomized Controlled Phase III Clinical Trial of PD-1 Monoclonal Antibody Plus Anlotinib Combined With Induction and Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma.

Not yet recruitingPH IIISun Yat-sen Universityn=4422032

A Prospective, Randomized, Open-Label, Multicenter Phase III Clinical Study Comparing Intensity-Modulated Proton Therapy and Intensity-Modulated Photon Radiotherapy in Locally Advanced Nasopharyngeal Carcinoma

RecruitingPH IIIMan Hun=3002031

A Prospective, Randomized Controlled Study of Perioperative Disitamab Vedotin Plus Immunotherapy Versus Chemotherapy Plus Immunotherapy in Patients With Resectable HER2-Expressing Muscle-Invasive Bladder Cancer (HOPE-07-MIBC Study)

Not yet recruitingPH II/IIIWest China Hospitaln=2402030

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HMPL-453 Tartrate as Monotherapy and in Combination With Chemotherapy or Toripalimab in Patients With Advanced Solid Tumors

CompletedPH I/IIHutchison Medipharma Limitedn=1902026

A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab and With Standard Chemotherapy in Patients With Advanced Lung Cancer

CompletedPH I/IIShanghai Junshi Bioscience Co., Ltd.n=1192025

A Phase 1/1b Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors

CompletedPH ICoherus Oncology, Inc.n=1452025

A Phase I/II Study of Evaluating the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics and Curative Effect of Dose Escalation and Extension for Single Drug TJ004309 and Toripalimab Combine Treatment for Advanced Solid Tumor

CompletedPH I/IITJ Biopharma Co., Ltd.n=2252025

Phase II Study of Neoadjuvant Toripalimab in Combination With Gemcitabine Therapy in Cisplatin Ineligible Stage II-IIIB Bladder Cancer

CompletedPH IIHenan Cancer Hospitaln=502025

Neoadjuvant PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced Anal Canal Squamous Carcinoma Patients

CompletedPH IISun Yat-sen Universityn=252024
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.