Penpulimab clinical trials
Penpulimab is named as an intervention in 19 current clinical trials in our China, USA, Canada, Brazil and Australia registers. 11 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Akeso (2). The most-studied condition is Head and Neck Squamous Cell Carcinoma.
Where Penpulimab is approved
All regulators →Of the three regulators tracked here, the first to approve Penpulimab was the US, on 23 Apr 2025.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
How Penpulimab works
All drug targets →- Programmed cell death protein 1 inhibitor InhibitorTarget: PDCD1 programmed cell death 1✓ In ChEMBL and the Guide to Pharmacology
- Classic Hodgkin lymphomaPhase 3
- Gastric adenocarcinomaPhase 3
- Hepatocellular carcinomaPhase 3
- Nasopharyngeal carcinomaPhase 3
- Non-small cell lung carcinomaPhase 3
- Non-small cell squamous lung carcinomaPhase 3
- Breast cancerPhase 2
- Cervical cancerPhase 2
- Colorectal cancerPhase 2
- Differentiated thyroid carcinomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297571, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 12347, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Penpulimab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Penpulimab
19 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Conditions studied with Penpulimab
31 conditionsAll 31 conditions
| Condition (as registered) | Trials |
|---|---|
| Head and Neck Squamous Cell Carcinoma | 3 |
| Nasopharyngeal Carcinoma | 2 |
| Esophageal Cancer | 1 |
| Advanced Pancreatic Cancer | 1 |
| Squamous Non-Small Cell Lung Cancer sqNSCLC | 1 |
| Extensive-stage Small Cell Lung Cancer (ES-SCLC) | 1 |
| Soft Tissue Sarcoma (STS) | 1 |
| Primary Central Nervous System Lymphoma | 1 |
| Diffuse Large B-Cell Lymphoma | 1 |
| Non-small Cell Lung Cancer Stage IIIB/IV | 1 |
| Head and Neck Squamous Cell Carcinoma (HNSCC) | 1 |
| Colorectal Adenocarcinoma | 1 |
| Advanced Solid Tumors | 1 |
| Head and Neck Neoplasms | 1 |
| Recurrent Disease | 1 |
| Metastatic Cancer | 1 |
| Resectable Locally Advanced Non-small Cell Lung Cancer | 1 |
| Rectal Cancer | 1 |
| Locally Advanced | 1 |
| Gastroesophageal Adenocarcinoma | 1 |
| Soft Tissue Sarcoma | 1 |
| Melanoma | 1 |
| Advanced Solid Tumor | 1 |
| NSCLC | 1 |
| Neoadjuvant Therapy | 1 |
| Immunotherapy | 1 |
| AK112 | 1 |
| Carcinoma | 1 |
| Gastrointestinal Diseases | 1 |
| Stomach Cancer | 1 |
| Gastroesophageal-junction Cancer | 1 |
Sponsors
lead sponsor per trial+ 1 more sponsors in the trial list above.
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 19 | 11 |
| Clinical trials in USA | 1 | 0 |
| Clinical trials in Canada | 1 | 0 |
| Clinical trials in Brazil | 1 | 0 |
| Clinical trials in Australia | 1 | 0 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Penpulimab trials
How many clinical trials are testing Penpulimab?
19 current trials in our China, USA, Canada, Brazil and Australia registers name Penpulimab (also registered as AK-105) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Penpulimab trials recruiting patients?
Yes. 11 of the 19 trials are recruiting: 11 with sites in China. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Penpulimab clinical trials?
Akeso (2), Chia Tai Tianqing Pharmaceutical Group Co., Ltd (2), Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd (2) and Xijing Hospital (1), among 16 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Penpulimab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Penpulimab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Penpulimab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.