> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/alirocumab-94bb5dc8-32f2-4ed6-a82e-b554472e2cd5 > Record changed: 2026-10-13 # Alirocumab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109540) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109540) First approval year 2015 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109540) ## Development status **First approval year** 2015 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109540) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109540) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109540) **Drug name** Alirocumab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109540) ### Brand names (2) - praluent - Praluent ### Other names (32) - alirocumab - Alirocumab - Alirocumab (Lyophilized formulation) - alirocumab \[INN\] - ALIROCUMAB \[JAN\] - ALIROCUMAB \[MI\] - ALIROCUMAB \[PURPLE BOOK CDER\] - ALIROCUMAB \[USAN\] - Alirocumab \[WHO-DD\] - Alirocumab 150 mg - alirocumab inn - alirocumab jan - alirocumab mi - alirocumab purple book cder - alirocumab SAR236553 (REGN727) - Alirocumab SAR236553 (REGN727) - ALIROCUMAB SAR236553 (REGN727) - alirocumab usan - alirocumab who dd - immunoglobulin g1 anti human neural apoptosis regulated proteinase 1 human regn727 heavy chain disulfide with human regn727 kappa chain dimer - IMMUNOGLOBULIN G1, ANTI-(HUMAN NEURAL APOPTOSIS-REGULATED PROTEINASE 1) (HUMAN REGN727 HEAVY CHAIN), DISULFIDE WITH HUMAN REGN727 .KAPPA.-CHAIN, DIMER - Praluent - Praluent (Alirocumab) - regn 727 - REGN-727 And 7 more, listed on the interactive page. ## Identifiers **ATC classification codes** - C10AX14 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109540) **CAS registry numbers** - 1245916-14-6 **ChEMBL ID** CHEMBL2109540 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109540) **RxNorm IDs (RxCUI)** - 1659152 **FDA ingredient codes (UNII)** - PP0SHH6V16 ## Regulatory information ### United States **Applicant** REGENERON PHARMACEUTICALS **Approval date** 24 Jul 2015 **Application number** BLA125559 ### European Union **Status** Authorised **Status date** 23 Sept 2015 **Authorisation date** 23 Sept 2015 **Approved indications** Primary hypercholesterolaemia and mixed dyslipidaemia Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet: - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Established atherosclerotic cardiovascular disease Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: - in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1. **Product number** EMEA/H/C/003882 **Authorisation holder** Sanofi Winthrop Industrie **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Dyslipidemias European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/praluent) ### Other regulatory facts **Patents** 0 **Designations** 1 **Earliest recorded loss of exclusivity** 1 Apr 2028 **First in class** Yes **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** alirocumab **Type** Antibody **Drug name stem** \-mab **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (2) - **Action** Binding **Action type** Binding **Target** proprotein convertase subtilisin/kexin type 9 **Gene symbol** PCSK9 **Protein identifier** Q8NBP7 **Median affinity** 9.42 **Affinity units** pKd **Primary target** Yes - **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 (11) - **Condition** Cardiovascular Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0000319 **Subject identifier** D002318 - **Condition** Diabetes Mellitus **Highest recorded phase** 3 **Condition identifier** EFO:0000400 **Subject identifier** D003920 - **Condition** Coronary Artery Disease **Highest recorded phase** 4 **Condition identifier** EFO:0001645 **Subject identifier** D003324 - **Condition** Atherosclerosis **Highest recorded phase** 4 **Condition identifier** EFO:0003914 **Subject identifier** D050197 - **Condition** Nephrotic Syndrome **Highest recorded phase** 2 **Condition identifier** EFO:0004255 **Subject identifier** D009404 - **Condition** Hyperlipoproteinemia Type II **Highest recorded phase** 4 **Condition identifier** EFO:0004911 **Subject identifier** D006938 - **Condition** Dyslipidemias **Highest recorded phase** 4 **Condition identifier** HP:0003119 **Subject identifier** D050171 - **Condition** Hypercholesterolemia **Highest recorded phase** 3 **Condition identifier** HP:0003124 **Subject identifier** D006937 - **Condition** Sepsis **Highest recorded phase** 1 **Condition identifier** HP:0100806 **Subject identifier** D018805 - **Condition** Hyperlipoproteinemia Type II **Highest recorded phase** 4 **Condition identifier** MONDO:0018328 **Subject identifier** D006938 - **Condition** Lipid Metabolism Disorders **Highest recorded phase** 3 **Condition identifier** Orphanet:309005 **Subject identifier** D052439 ### Open Targets indications (32) - **Condition identifier** EFO\_0000319 - **Condition identifier** EFO\_0000400 **Highest recorded phase** 3 - **Condition identifier** EFO\_0001645 - **Condition identifier** EFO\_0003914 - **Condition identifier** EFO\_0004255 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004264 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004911 - **Condition identifier** EFO\_0006834 **Highest recorded phase** 2 - **Condition identifier** EFO\_0020921 - **Condition identifier** HP\_0001297 - **Condition identifier** HP\_0003119 - **Condition identifier** HP\_0003119 **Highest recorded phase** 4 - **Condition identifier** HP\_0003124 - **Condition identifier** HP\_0003124 **Highest recorded phase** 4 - **Condition identifier** HP\_0100806 **Highest recorded phase** 1 - **Condition identifier** HP\_0100806 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0002525 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0004781 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0004995 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005010 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005068 - **Condition identifier** MONDO\_0005147 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005148 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005233 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005264 And 7 more, listed on the interactive page. ### Reported adverse events (24) - **Event** arthralgia **Reports** 223 **Reporting signal score** 65.1808 - **Event** blood cholesterol increased **Reports** 59 **Reporting signal score** 57.101 - **Event** blood triglycerides increased **Reports** 49 **Reporting signal score** 61.9818 - **Event** device defective **Reports** 26 **Reporting signal score** 53.1357 - **Event** device operational issue **Reports** 54 **Reporting signal score** 222.703 - **Event** device use issue **Reports** 83 **Reporting signal score** 244.546 - **Event** influenza like illness **Reports** 199 **Reporting signal score** 272.267 - **Event** injection site bruising **Reports** 155 **Reporting signal score** 201.952 - **Event** injection site erythema **Reports** 155 **Reporting signal score** 99.2014 - **Event** injection site haemorrhage **Reports** 85 **Reporting signal score** 95.7794 - **Event** injection site pain **Reports** 222 **Reporting signal score** 124.5 - **Event** injection site pruritus **Reports** 106 **Reporting signal score** 89.123 - **Event** injection site rash **Reports** 92 **Reporting signal score** 137.195 - **Event** injection site swelling **Reports** 98 **Reporting signal score** 70.0564 - **Event** injury associated with device **Reports** 85 **Reporting signal score** 202.181 - **Event** low density lipoprotein decreased **Reports** 38 **Reporting signal score** 121.715 - **Event** low density lipoprotein increased **Reports** 182 **Reporting signal score** 576.629 - **Event** muscle spasms **Reports** 211 **Reporting signal score** 180.963 - **Event** myalgia **Reports** 403 **Reporting signal score** 520.187 - **Event** pain in extremity **Reports** 196 **Reporting signal score** 81.6425 - **Event** product administered at inappropriate site **Reports** 67 **Reporting signal score** 212.754 - **Event** product dose omission issue **Reports** 141 **Reporting signal score** 172.398 - **Event** rhinorrhoea **Reports** 88 **Reporting signal score** 90.8889 - **Event** wrong technique in device usage process **Reports** 93 **Reporting signal score** 281.881 ### Trial references (48) - NCT01161082 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01161082) - NCT01266876 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01266876) - NCT01288443 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01288443) - NCT01288469 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01288469) - NCT01443650 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01443650) - NCT01448239 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01448239) - NCT01448304 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01448304) - NCT01448317 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01448317) - NCT01507831 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01507831) - NCT01576484 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01576484) - NCT01604824 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01604824) - NCT01623115 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01623115) - NCT01644175 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01644175) - NCT01644188 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01644188) - NCT01644474 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01644474) - NCT01670734 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01670734) - NCT01709513 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01709513) - NCT01723735 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01723735) - NCT01730040 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01730040) - NCT01730053 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01730053) - NCT01785329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01785329) - NCT01812707 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01812707) - NCT01926782 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01926782) - NCT01954394 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01954394) - NCT01959971 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01959971) And 23 more, listed on the interactive page. ## Dosing **Dose** 75 mg or 150 mg or 300 mg **Route** Subcutaneous **How often** Every 2 weeks or every 4 weeks ### Conditions of use - Rotate injection sites ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (2) - **Component** Heavy chain **Type** Protein **Organism** Homo sapiens **Sequence** EVQLVESGGGLVQPGGSLRLSCAASGFTFNNYAMNWVRQAPGKGLDWVSTISGSGGTTNYADSVKGRFIISRDSSKHTLYLQMNSLRAEDTAVYYCAKDSNWGNFDLWGRGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG - **Component** Light chain **Type** Protein **Organism** Homo sapiens **Sequence** DIVMTQSPDSLAVSLGERATINCKSSQSVLYRSNNRNFLGWYQQKPGQPPNLLIYWASTRESGVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCQQYYTTPYTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC ## National Drug Codes - 0024-5901 - 0024-5902 - 61755-020 - 61755-021 ## Related records ### Trials (98) - A Study of Alirocumab in Participants With Autosomal Dominant Hypercholesterolemia (ADH) and Gain-of-Function Mutations (GOFm) of the Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Gene or Loss-of-Function Mutations (LOFm) of the Apolipoprotein (Apo) B Gene - A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects - [A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia](https://trialight.com/data/trial/a-study-to-see-how-safe-and-effective-alirocumab-is-when-cb1b958f-1198-45d0-a2e4-eeadfc2d0af2.md) - A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease - Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma - Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD) - Alirocumab and Plaque Burden In Familial Hypercholesterolaemia - Alirocumab and Reverse Cholesterol Transport - Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque - Alirocumab in Patients on a Stable Dialysis Regimen - Alirocumab in Patients With Acute Myocardial Infarction - Alirocumab in Patients with Sepsis - An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia - An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia - An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia - Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers - Ascending Dose Study of the Safety and Tolerability of REGN727 (SAR236553) in Healthy Volunteers - Ascending Dose Study of the Safety and Tolerability of REGN727(SAR236553) in Healthy Volunteers - Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin - Assessment of Atherosclerotic Plaque Characteristics Change by DCE-MRI With Alirocumab ### Approved for (5) - [Atherosclerosis](https://trialight.com/data/condition/atherosclerosis-5dab64e9-1fd4-5dd2-90c2-ce84935652d1.md) - [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md) - [Coronary artery disorder](https://trialight.com/data/condition/coronary-artery-disorder-6f736849-d477-587a-b3fa-b0621d573407.md) - [Familial hypercholesterolemia](https://trialight.com/data/condition/familial-hypercholesterolemia-ee6bd6b4-71cd-509a-9360-eb8a7c2bd428.md) - Homozygous familial hypercholesterolemia ### In development for (4) - [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) Phase 3 - Inherited lipid metabolism disorder Phase 3 - Nephrotic syndrome Phase 2 - Vascular disorder 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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