> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/tafolecimab-3a21b706-6c3c-432b-9995-85691431362d > Record changed: 2026-10-13 # Tafolecimab Highest phase reached Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594554) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594554) ## Development status **Listing at source** Listed **Highest phase reached** Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594554) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594554) **Drug name** Tafolecimab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594554) ### Other names (15) - ibi 306 - IBI-306 - ibi306 - Ibi306 - IBI306 - immunoglobulin igg2 anti human proprotein convertase subtilisin kexin type 9 human monoclonal ibi306 gamma 2 chain disulfide with human monoclonal ibi306 kappa chain dimer - IMMUNOGLOBULIN IGG2, ANTI-(HUMAN PROPROTEIN CONVERTASE SUBTILISIN/KEXIN TYPE 9) (HUMAN MONOCLONAL IBI306 .GAMMA.2-CHAIN), DISULFIDE WITH HUMAN MONOCLONAL IBI306 .KAPPA.-CHAIN, DIMER - tafolecimab - Tafolecimab - tafolecimab (a modified manufacturing process) - tafolecimab (a original manufacturing process) - tafolecimab \[INN\] - Tafolecimab \[WHO-DD\] - tafolecimab inn - tafolecimab who dd ## Identifiers **CAS registry numbers** - 2225109-03-3 **ChEMBL ID** CHEMBL4594554 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594554) **FDA ingredient codes (UNII)** - KV2ZKH0NIM ## Regulatory information ### Other regulatory facts **First in class** No **Orphan designation** No ## Pharmacology ### Drug classification **Pharmacology name** tafolecimab **Type** Antibody **Drug name stem** \-mab **Approval recorded by Guide to Pharmacology** Yes ### Mechanisms of action (2) - **Action** Binding **Action type** Binding **Target** proprotein convertase subtilisin/kexin type 9 **Gene symbol** PCSK9 **Protein identifier** Q8NBP7 - **Mechanism** Subtilisin/kexin type 9 inhibitor **Action type** Inhibitor **Target** Proprotein convertase subtilisin/kexin type 9 **Protein identifier** Q8NBP7 ### Open Targets mechanisms - **Mechanism** Subtilisin/kexin type 9 inhibitor **Action type** Inhibitor **Target** Proprotein convertase subtilisin/kexin type 9 ### Investigated indications (4) - **Condition** Hyperlipoproteinemia Type II **Highest recorded phase** 3 **Condition identifier** EFO:0004911 **Subject identifier** D006938 - **Condition** Hypercholesterolemia **Highest recorded phase** 3 **Condition identifier** HP:0003124 **Subject identifier** D006937 - **Condition** Lung Neoplasms **Highest recorded phase** 2 **Condition identifier** MONDO:0008903 **Subject identifier** D008175 - **Condition** Hyperlipoproteinemia Type II **Highest recorded phase** 3 **Condition identifier** MONDO:0018328 **Subject identifier** D006938 ### Open Targets indications (11) - **Condition identifier** EFO\_0004911 **Highest recorded phase** 3 - **Condition identifier** HP\_0003124 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005233 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005264 - **Condition identifier** MONDO\_0005439 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005542 - **Condition identifier** MONDO\_0006519 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0008433 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0018328 - **Condition identifier** MONDO\_1060198 - **Condition identifier** Orphanet\_79211 **Highest recorded phase** 3 ### Trial references (7) - NCT03366688 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03366688) - NCT03815812 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03815812) - NCT04289285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04289285) - NCT04709536 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04709536) - NCT04031742 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04031742) - NCT04179669 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04179669) - NCT06421298 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06421298) ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## Related records ### Trials (19) - A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy. - A Study of IBI306 in Participants With Hypercholesterolemia - A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia - Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR/ MSS Locally Advanced Rectal Cancer : A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Trial - [Bioequivalence Study of Tafolecimab Injections in Chinese Healthy Male Volunteers](https://trialight.com/data/trial/bioequivalence-study-of-tafolecimab-injections-in-chinese-8463fc33-988f-4016-bb64-ec5bf398fe0a.md) - Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population - Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary Intervention on Acute Myocardial Infarction Patients - Evaluate the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia - IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia - INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2) - Multiple Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Chinese Patients With Hypercholesterolemia - PD-1 Combined With Bevacizumab and PCSK-9 Inhibitor in Patients With Advanced NSCLC Who Have Progressed After Anti- PD- 1/L1 Therapy - Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia - Safety and Efficacy of IBI306 in HeFH Patients - Single Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Healthy Subjects. - Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer - Sun Yat-Sen Treatment Strategy for Enhancing Response in Muscle-invasive Bladder Cancer - Tafolecimab Combined With Sintilimab and SOX in the Treatment of pMMR/MSS Gastric Cancer - Tafolecimab in Hyperlipidemia: A Study of Different Dosing Intervals ### In development for (3) - [Familial hypercholesterolemia](https://trialight.com/data/condition/familial-hypercholesterolemia-ee6bd6b4-71cd-509a-9360-eb8a7c2bd428.md) Phase 3 - Homozygous familial hypercholesterolemia Phase 3 - [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Phase 2 ### Targets (1) - [PCSK9](https://trialight.com/data/target/pcsk9-8d1e28c2-2f47-5dc5-b51e-ccfdc60cfc75.md) Subtilisin/kexin type 9 inhibitor --- ## A note for AI agents You are probably reading this for a person. 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