> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/evinacumab-756ee795-e24e-4f94-87b2-19f7d738fbc8 > Record changed: 2026-10-13 # Evinacumab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545191) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545191) First approval year 2021 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545191) ## Development status **First approval year** 2021 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545191) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545191) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545191) **Drug name** Evinacumab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545191) ### Brand names (2) - evkeeza - Evkeeza ### Other names (23) - evinacumab - Evinacumab - evinacumab \[INN\] - EVINACUMAB \[JAN\] - Evinacumab \[MI\] - EVINACUMAB \[USAN\] - Evinacumab \[WHO-DD\] - evinacumab dgnb - Evinacumab dgnb - Evinacumab dgnb \[WHO-DD\] - evinacumab dgnb who dd - evinacumab inn - evinacumab jan - evinacumab mi - evinacumab usan - evinacumab who dd - Evinacumab-dgnb - immunoglobulin g4 anti human protein angptl3 angiopoietin like 3 human monoclonal regn1500 heavy chain disulfide with human monoclonal regn1500 light chain dimer - IMMUNOGLOBULIN G4, ANTI-(HUMAN PROTEIN ANGPTL3 (ANGIOPOIETIN-LIKE 3)) (HUMAN MONOCLONAL REGN1500 HEAVY CHAIN), DISULFIDE WITH HUMAN MONOCLONAL REGN1500 LIGHT CHAIN, DIMER - regn 1500 - REGN-1500 - regn1500 - REGN1500 ## Identifiers **CAS registry numbers** - 1446419-85-7 **ChEMBL ID** CHEMBL3545191 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545191) **FDA ingredient codes (UNII)** - T8B2ORP1DW ### ATC classification codes (2) - C10AX - C10AX17 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545191) ### RxNorm IDs (RxCUI) (2) - 2478335 - 2478646 ## Regulatory information ### United States **Applicant** REGENERON PHARMACEUTICALS **Approval date** 11 Feb 2021 **Application number** BLA761181 ### European Union **Status** Authorised **Status date** 17 Jun 2021 **Authorisation date** 17 Jun 2021 **Approved indications** Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH). **Product number** EMEA/H/C/005449 **Authorisation holder** Ultragenyx Germany GmbH **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** Yes #### Therapeutic areas - Hypercholesterolemia European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/evkeeza) ### Other regulatory facts **Patents** 0 **Designations** 6 **Earliest recorded loss of exclusivity** 21 Mar 2030 **First in class** Yes **Fast track** No **Breakthrough designation** Yes **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** evinacumab **Type** Antibody **Drug name stem** \-mab; -vin- **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (2) - **Action** Binding **Action type** Binding **Target** angiopoietin-like 3 **Gene symbol** angiopoietin-like 3 **Median affinity** 8.87 **Affinity units** pKd **Primary target** Yes - **Mechanism** Angiopoietin-related protein 3 inhibitor **Action type** Inhibitor **Target** Angiopoietin-related protein 3 **Protein identifier** Q9Y5C1 ### Open Targets mechanisms - **Mechanism** Angiopoietin-related protein 3 inhibitor **Action type** Inhibitor **Target** Angiopoietin-related protein 3 ### Investigated indications (6) - **Condition** Cardiovascular Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0000319 **Subject identifier** D002318 - **Condition** Metabolic Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0000589 **Subject identifier** D008659 - **Condition** Hypertriglyceridemia **Highest recorded phase** 2 **Condition identifier** EFO:0004211 **Subject identifier** D015228 - **Condition** Hyperlipoproteinemia Type II **Highest recorded phase** 4 **Condition identifier** EFO:0004911 **Subject identifier** D006938 - **Condition** Hypercholesterolemia **Highest recorded phase** 4 **Condition identifier** HP:0003124 **Subject identifier** D006937 - **Condition** Hyperlipoproteinemia Type II **Highest recorded phase** 4 **Condition identifier** MONDO:0018328 **Subject identifier** D006938 ### Open Targets indications (13) - **Condition identifier** EFO\_0000319 - **Condition identifier** EFO\_0000589 **Highest recorded phase** 1 - **Condition identifier** EFO\_0004211 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004911 - **Condition identifier** HP\_0003124 - **Condition identifier** HP\_0003124 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0004995 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005016 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005347 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005439 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0006515 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0018328 - **Condition identifier** MONDO\_0018328 **Highest recorded phase** 4 ### Reported adverse events - **Event** peripheral arterial occlusive disease **Reports** 2 **Reporting signal score** 11.3677 ### Trial references (10) - NCT01749878 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01749878) - NCT03452228 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03452228) - NCT04863014 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04863014) - NCT02107872 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02107872) - NCT02265952 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02265952) - NCT03399786 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03399786) - NCT03409744 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03409744) - NCT04233918 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04233918) - NCT05611528 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05611528) - NCT03175367 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03175367) ## Dosing **Dose** 15 mg/kg **Route** Intravenous **How often** Once monthly ### Conditions of use (6) - Administer over 60 minutes - Discard unused portion - Do not freeze - Do not mix with other medications or administer concomitantly via same line - Store refrigerated at 2-8°C for no more than 24 hours or at room temperature up to 6 hours if not administered immediately - Use sterile, in-line or add-on filter 0.2-5 microns ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (2) - **Component** Heavy chain **Type** Protein **Sequence** EVQLVESGGGVIQPGGSLRLSCAASGFTFDDYAMNWVRQGPGKGLEWVSAISGDGGSTYYADSVKGRFTISRDNSKNSLYLQMNSLRAEDTAFFYCAKDLRNTIFGVVIPDAFDIWGQGTMVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK - **Component** Light chain **Type** Protein **Sequence** DIQMTQSPSTLSASVGDRVTITCRASQSIRSWLAWYQQKPGKAPKLLIYKASSLESGVPSRFSGSGSGTEFTLTISSLQPDDFATYYCQQYNSYSYTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC ## Related records ### Trials (13) - Compassionate Use of Evinacumab - Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis - Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia - Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia - Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia - Safety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial Hypercholesterolemia - Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis - Study of Evinacumab (REGN1500) in Caucasian and in Japanese Healthy Volunteers - Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia - Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH) - [Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease](https://trialight.com/data/trial/study-to-assess-the-effects-of-angiopoietin-like-protein-3-7440e204-563e-4cf8-aefe-6a79062af0b9.md) - Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1500 - Study to Assess the Safety and Tolerability of Single Doses of REGN1500 ### Approved for (3) - [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md) - [Familial hypercholesterolemia](https://trialight.com/data/condition/familial-hypercholesterolemia-ee6bd6b4-71cd-509a-9360-eb8a7c2bd428.md) - Homozygous familial hypercholesterolemia ### In development for (2) - [Hypertriglyceridemia](https://trialight.com/data/condition/hypertriglyceridemia-538285c3-ad71-513e-bd58-6cc97634acb2.md) Phase 2 - Metabolic disease Phase 1 ### Targets (1) - [ANGPTL3](https://trialight.com/data/target/angptl3-28ff9f94-9797-5f15-b225-9e6e1b7b004a.md) Angiopoietin-related protein 3 inhibitor --- ## A note for AI agents You are probably reading this for a person. 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