penpulimab
mAbapprovedOrphan Drug FDA
Approved
Apr 23, 2025
Clinical trial activity
61 trials · 24 clinical orgs · 1 marketing orgs
Phase 1
16
Phase 2
45
Phase 3
5
Phase 4
2
Earliest trial started Dec 28, 2020 (NCT05001971)
Timeline
2020s
- Jan 1, 2020
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2021
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2021
Akeso Pharmaceuticals, Inc. — Earliest Phase 3 Sponsor(trial)
- Feb 23, 2021
Orphan Drug Designation
- Apr 23, 2025
Earliest FDA Approval
- Apr 23, 2025
Akeso Pharmaceuticals, Inc. — Marketing Organization
Indications
Approved for
Studied for
- Angiogenesis Modulating Agents · Phase 3
- Antibodies, Monoclonal · Phase 2
- Breast Neoplasms · Phase 2
- Carcinoma · Phase 2
- Carcinoma, Hepatocellular · Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 4
- Carcinoma, Squamous Cell · Phase 1/Phase 2
- Colorectal Neoplasms · Phase 2
- Digestive System Diseases · Phase 2
- Drug Resistance · Phase 3
- Drugs, Investigational · Phase 1/Phase 2
- Drug Therapy · Phase 3
- Esophageal Neoplasms · Phase 2
- Esophageal Squamous Cell Carcinoma · Phase 2
- Essential Tremor · Phase 2
- Gastrointestinal Diseases · Phase 2
- Gastrointestinal Neoplasms · Phase 2
- Genes, erbB-1 · Phase 3
- Genital Neoplasms, Female · Phase 2
- Glioma · Phase 2
- Head and Neck Neoplasms · Phase 2
- Hodgkin Disease · Phase 2
- Immunotherapy · Phase 2
- Lung Neoplasms · Phase 3
- Lymphoma · Phase 3
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Melanoma · Phase 2
- Nasopharyngeal Carcinoma · Phase 3
- Nasopharyngeal Neoplasms · Phase 2
- Neoadjuvant Therapy · Phase 2
- Neoplasm Metastasis · Phase 2
- Neoplasms by Histologic Type · Phase 2
- Osteosarcoma · Phase 2
- Pancreatic Neoplasms · Phase 2
- Pheochromocytoma · Phase 2
- Rectal Neoplasms · Phase 2
- Sarcoma · Phase 2
- Small Cell Lung Carcinoma · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- Stomach Neoplasms · Phase 2
- Urinary Bladder Neoplasms · Phase 4
- Uterine Cervical Neoplasms · Phase 2
Mechanism of action
- Programmed cell death protein 1ANTAGONIST
PD1
- Programmed cell death protein 1INHIBITOR
Programmed cell death protein 1 inhibitor
Approval history
- approvedApr 23, 2025
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4297571 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07075419 | Phase 1/Phase 2 (Phase 2) | Aug 1, 2025 | Sichuan University |
| NCT07086326 | Phase 2 | Jul 31, 2025 | Peking University |
| NCT06943820 | Phase 1/Phase 2 (Phase 2) | May 21, 2025 | Akeso Pharmaceuticals, Inc. |
| NCT06825494 | Phase 1/Phase 2 (Phase 2) | Apr 8, 2025 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT06821503 | Phase 1/Phase 2 (Phase 2) | Feb 28, 2025 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT06649656 | Phase 1 | Nov 30, 2024 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT06767800 | Phase 2 | Nov 21, 2024 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT06516978 | Phase 2 | Oct 1, 2024 | Nanjing Medical University |
| NCT06853769 | Early Phase 1 (Phase 1) | Sep 1, 2024 | Nanjing Medical University |
| NCT06500091 | Phase 2 | Jul 31, 2024 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT06444009 | Phase 2 | Jul 1, 2024 | Sichuan University |
| NCT06297642 | Phase 1 | May 24, 2024 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT06429397 | Phase 2 | May 15, 2024 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd, Sun Yat-Sen University |
| NCT06320080 | Phase 1 | Apr 30, 2024 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT06341530 | Phase 2 | Jan 31, 2024 | Zhengzhou University |
| NCT06062563 | N/A | Nov 11, 2023 | Chinese Academy of Medical Sciences |
| NCT06081673 | Phase 2 | Oct 30, 2023 | Jiao Tong University |
| NCT05807880 | Phase 2 | Oct 1, 2023 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd, Sun Yat-Sen University |
| NCT06048315 | Phase 3 | Sep 30, 2023 | Shandong Province Qianfoshan Hospital, Wu Jieping Medical Foundation |
| NCT06010901 | Phase 1 | Sep 30, 2023 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
Showing 20 of 61 trials
Page 1 / 4
Organizations
Research & Development (24)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd | For profit | 23 | 15 | 3 | 2020 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 6 | 5 | 4 | 2021 |
| Nanjing Medical University | Academic/Hospital | 6 | 6 | 3 | 2022 |
| Fudan University | Academic/Hospital | 4 | 3 | 3 | 2021 |
| Sun Yat-Sen University | Academic/Hospital | 4 | 4 | 2 | 2022 |
| Akeso Pharmaceuticals, Inc. | For profit | 3 | 3 | 2 | 2021 |
| Jiao Tong University | Academic/Hospital | 3 | 3 | 1 | 2022 |
| Peking University | Academic/Hospital | 3 | 2 | 2 | 2022 |
| Sichuan University | Academic/Hospital | 3 | 3 | 1 | 2023 |
| Xijing Hospital | Academic/Hospital | 3 | 3 | 2 | 2022 |
| Zhengzhou University | Academic/Hospital | 3 | 3 | 1 | 2022 |
| Air Force Military Medical University, China | Academic/Hospital | 2 | 0 | 1 | 2022 |
| Central South University | Academic/Hospital | 2 | 2 | 1 | 2020 |
| Nanjing University | Academic/Hospital | 2 | 2 | 1 | 2022 |
| Southern Medical University | Academic/Hospital | 2 | 1 | 2 | 2022 |
| Fujian Medical University | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Henan Medical University | Academic/Hospital | 1 | 0 | 1 | 2022 |
| People's Liberation Army of China | Government | 1 | 1 | 1 | 2022 |
| Shandong Province Qianfoshan Hospital | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Southeast University | Academic/Hospital | 1 | 1 | 1 | 2022 |
24 organizations
Page 1 / 2
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Akeso Pharmaceuticals, Inc. | For profit | MKTG | Apr 23, 2025 |