> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/evolocumab-ece543fe-0502-44c3-bef4-ec566503cced
> Record changed: 2026-10-13

# Evolocumab

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364655)

Drug type

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364655)

First approval year

2015

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364655)

## Development status

**First approval year**

2015

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364655)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364655)

## Names and chemistry

**Drug type**

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364655)

**Drug name**

Evolocumab

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364655)

### Brand names (4)

- repatha
- Repatha
- repatha sureclick
- Repatha sureclick

### Other names (23)

- amg 145
- AMG-145
- evolocumab
- Evolocumab
- EVOLOCUMAB (GENETICAL RECOMBINATION)
- evolocumab \[INN\]
- EVOLOCUMAB \[JAN\]
- EVOLOCUMAB \[MI\]
- EVOLOCUMAB \[PURPLE BOOK CDER\]
- EVOLOCUMAB \[USAN\]
- Evolocumab \[WHO-DD\]
- evolocumab genetical recombination
- evolocumab inn
- evolocumab jan
- evolocumab mi
- evolocumab purple book cder
- evolocumab usan
- evolocumab who dd
- Evolocumab(420 mg injections)
- immunoglobulin g2 lambda anti homo sapiens pcsk9 proprotein convertase subtilisin kexin type 9 homo sapiens monoclonal antibody
- IMMUNOGLOBULIN G2-LAMBDA, ANTI-(HOMO SAPIENS PCSK9 (PROPROTEIN CONVERTASE SUBTILISIN/KEXIN TYPE 9)), HOMO SAPIENS MONOCLONAL ANTIBODY
- Repatha
- Repatha®

## Identifiers

**ATC classification codes**

- C10AX13

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364655)

**CAS registry numbers**

- 1256937-27-5

**ChEMBL ID**

CHEMBL2364655

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364655)

**RxNorm IDs (RxCUI)**

- 1665684

**FDA ingredient codes (UNII)**

- LKC0U3A8NJ

## Regulatory information

### United States

**Applicant**

AMGEN INC

**Approval date**

27 Aug 2015

**Application number**

BLA125522

### European Union

**Status**

Authorised

**Status date**

17 Jul 2015

**Authorisation date**

17 Jul 2015

**Approved indications**

Hypercholesterolaemia and mixed dyslipidaemia Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, 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. Homozygous familial hypercholesterolaemia Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. Established atherosclerotic cardiovascular disease Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial 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/003766

**Authorisation holder**

Amgen Europe B.V.

**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
- Hypercholesterolemia

European medicines record

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/repatha)

### Other regulatory facts

**Patents**

0

**Designations**

1

**Earliest recorded loss of exclusivity**

24 Sept 2028

**First in class**

No

**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**

evolocumab

**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**

9.72

**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 (21)

- **Condition**  
Cardiovascular Diseases

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000319

**Subject identifier**  
D002318
- **Condition**  
Glioblastoma

**Highest recorded phase**

0.5

**Condition identifier**  
EFO:0000519

**Subject identifier**  
D005909
- **Condition**  
Myocardial Infarction

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000612

**Subject identifier**  
D009203
- **Condition**  
Stroke

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000712

**Subject identifier**  
D020521
- **Condition**  
Coronary Artery Disease

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0001645

**Subject identifier**  
D003324
- **Condition**  
Carcinoma, Non-Small-Cell Lung

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0003060

**Subject identifier**  
D002289
- **Condition**  
Heart Failure

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003144

**Subject identifier**  
D006333
- **Condition**  
Aortic Aneurysm, Abdominal

**Highest recorded phase**

0.5

**Condition identifier**  
EFO:0004214

**Subject identifier**  
D017544
- **Condition**  
Hyperlipoproteinemia Type II

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0004911

**Subject identifier**  
D006938
- **Condition**  
Acute Coronary Syndrome

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0005672

**Subject identifier**  
D054058
- **Condition**  
Carcinoma, Renal Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0005708

**Subject identifier**  
D002292
- **Condition**  
ST Elevation Myocardial Infarction

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0008585

**Subject identifier**  
D000072657
- **Condition**  
Dyslipidemias

**Highest recorded phase**  
4

**Condition identifier**  
HP:0003119

**Subject identifier**  
D050171
- **Condition**  
Hypercholesterolemia

**Highest recorded phase**  
4

**Condition identifier**  
HP:0003124

**Subject identifier**  
D006937
- **Condition**  
Sepsis

**Highest recorded phase**  
2

**Condition identifier**  
HP:0100806

**Subject identifier**  
D018805
- **Condition**  
Lung Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0008903

**Subject identifier**  
D008175
- **Condition**  
Hyperlipoproteinemia Type II

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0018328

**Subject identifier**  
D006938
- **Condition**  
Hyperlipidemias

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0021187

**Subject identifier**  
D006949
- **Condition**  
Severe Acute Respiratory Syndrome

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0100096

**Subject identifier**  
D045169
- **Condition**  
Lipid Metabolism Disorders

**Highest recorded phase**  
3

**Condition identifier**  
Orphanet:309005

**Subject identifier**  
D052439
- **Condition**  
Hyperlipidemia, Familial Combined

**Highest recorded phase**  
3

**Condition identifier**  
Orphanet:79211

**Subject identifier**  
D006950

### Open Targets indications (47)

- **Condition identifier**  
EFO\_0000319
- **Condition identifier**  
EFO\_0000612
- **Condition identifier**  
EFO\_0000712
- **Condition identifier**  
EFO\_0001645
- **Condition identifier**  
EFO\_0003144

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0004214
- **Condition identifier**  
EFO\_0004265
- **Condition identifier**  
EFO\_0004911
- **Condition identifier**  
EFO\_0005672

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0008585

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0008585

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0008586

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0010673

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0020921
- **Condition identifier**  
EFO\_0020925
- **Condition identifier**  
HP\_0001297

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0003124
- **Condition identifier**  
HP\_0003124

**Highest recorded phase**  
4
- **Condition identifier**  
HP\_0100806

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002525
- **Condition identifier**  
MONDO\_0002525

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0004781

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004995

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005010

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005068

**Highest recorded phase**  
4

And 22 more, listed on the interactive page.

### Reported adverse events (22)

- **Event**  
back pain

**Reports**  
2,952

**Reporting signal score**  
2,701.64
- **Event**  
blood cholesterol decreased

**Reports**  
217

**Reporting signal score**

602.75
- **Event**  
condition aggravated

**Reports**  
57

**Reporting signal score**

574.208
- **Event**  
device defective

**Reports**  
272

**Reporting signal score**

562.024
- **Event**  
device use error

**Reports**  
739

**Reporting signal score**  
1,067.51
- **Event**  
drug interaction

**Reports**  
19

**Reporting signal score**

568.668
- **Event**  
influenza like illness

**Reports**  
1,900

**Reporting signal score**  
2,482.33
- **Event**  
injection site bruising

**Reports**  
2,370

**Reporting signal score**  
3,973.88
- **Event**  
injection site haemorrhage

**Reports**  
1,588

**Reporting signal score**  
2,660.58
- **Event**  
injection site mass

**Reports**  
653

**Reporting signal score**

808.581
- **Event**  
injection site pain

**Reports**  
4,676

**Reporting signal score**  
5,444.37
- **Event**  
injection site swelling

**Reports**  
1,019

**Reporting signal score**

742.513
- **Event**  
injury associated with device

**Reports**  
464

**Reporting signal score**

825.308
- **Event**  
low density lipoprotein decreased

**Reports**  
359

**Reporting signal score**  
1,122.12
- **Event**  
low density lipoprotein increased

**Reports**  
524

**Reporting signal score**  
1,010.61
- **Event**  
muscle spasms

**Reports**  
1,612

**Reporting signal score**  
1,009.51
- **Event**  
myalgia

**Reports**  
2,971

**Reporting signal score**  
2,964.32
- **Event**  
nasopharyngitis

**Reports**  
1,284

**Reporting signal score**

632.668
- **Event**  
pain in extremity

**Reports**  
1,912

**Reporting signal score**

737.735
- **Event**  
rhinorrhoea

**Reports**  
2,177

**Reporting signal score**  
4,006.21
- **Event**  
wrong technique in device usage process

**Reports**  
284

**Reporting signal score**

534.321
- **Event**  
wrong technique in product usage process

**Reports**  
7,200

**Reporting signal score**  
14,713.8

### Trial references (48)

- NCT01133522  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01133522)
- NCT01375764  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01375764)
- NCT01375777  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01375777)
- NCT01380730  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01380730)
- NCT01763827  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01763827)
- NCT01763866  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01763866)
- NCT01763905  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01763905)
- NCT01763918  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01763918)
- NCT01854918  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01854918)
- NCT01953328  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01953328)
- NCT01984424  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01984424)
- NCT02189837  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02189837)
- NCT01375751  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01375751)
- NCT01624142  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01624142)
- NCT02392559  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02392559)
- NCT02624869  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02624869)
- NCT03331666  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03331666)
- NCT06231459  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06231459)
- NCT01439880  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01439880)
- NCT01516879  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01516879)
- NCT01652703  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01652703)
- NCT01813422  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01813422)
- NCT01849497  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01849497)
- NCT02304484  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02304484)
- NCT02585895  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02585895)

And 23 more, listed on the interactive page.

## Dosing

**Dose**

140 mg or 420 mg

**Route**

Subcutaneous

**How often**

Every 2 weeks or once monthly

### Conditions of use

- Rotate injection sites after each administration

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

### Sequences (2)

- **Component**  
Heavy chain

**Type**  
Protein

**Sequence**  
EVQLVQSGAEVKKPGASVKVSCKASGYTLTSYGISWVRQAPGQGLEWMGWVSFYNGNTNYAQKLQGRGTMTTDPSTSTAYMELRSLRSDDTAVYYCARGYGMDVWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGKEYKCKVSNKGLPAPIEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- **Component**  
Light chain

**Type**  
Protein

**Sequence**  
ESALTQPASVSGSPGQSITISCTGTSSDVGGYNSVSWYQQHPGKAPKLMIYEVSNRPSGVSNRFSGSKSGNTASLTISGLQAEDEADYYCNSYTSTSMVFGGGTKLTVLGQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS

## National Drug Codes

- 72511-143
- 72511-393
- 72511-501
- 72511-750
- 72511-760

## Related records

### Trials (181)

- A Clinical Trial of TQH2929 Injection in Patients With Acute Flare-up of Generalized Pustular Psoriasis
- A Cohort Study Comparing PCSK9 Inhibitor Plus Statin With Statin Monotherapy for Carotid Artery Stenosis
- A Phase I Clinical Trial of Single Subcutaneous Injection or Intravenous Infusion of SHR-1139 Injection in Healthy Chinese Subjects and Multiple Subcutaneous Injections in Patients With Moderate-to-severe Plaque Psoriasis
- A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)
- A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC
- A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis
- A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease
- A Study of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArterectomy
- A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
- A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
- A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
- Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis
- Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
- Allergy Immunotherapy for the Reduction of Asthma
- An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
- Analgesic Tolerance to Repeated Doses of Subcutaneous Morphine
- Antiplatelet Effects of Evolocumab in Patients With Peripheral Arterial Disease
- Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults With Hyperlipidemia on Stable Doses of a Statin
- Autologous Angiogenic Cell Precursors (ACPs) for the Treatment of Peripheral Artery Disease
- Bovine Intestinal Alkaline Phosphatase (bIAP) Modulating Rheumatoid Arthritis

### Approved for (6)

- [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
- [Myocardial infarction](https://trialight.com/data/condition/myocardial-infarction-b4e97483-7435-5701-81dc-26d955e420ec.md)
- [Stroke disorder](https://trialight.com/data/condition/stroke-disorder-f6ef16d6-34dc-5c87-b764-37f0b5b8d504.md)

### In development for (13)

- Abdominal aortic aneurysm Early phase 1
- [Acute coronary syndrome](https://trialight.com/data/condition/acute-coronary-syndrome-3d7c2c1f-86ca-5a25-913a-6f9a7e95f989.md) Phase 3
- [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 3
- Glioblastoma Early phase 1
- [Heart failure](https://trialight.com/data/condition/heart-failure-e230b1c3-ce91-5f80-b80f-81fc353ce5cc.md) Phase 2
- Hyperlipidemia Phase 3
- Hyperlipidemia, familial combined, LPL related Phase 3
- Inherited lipid metabolism disorder Phase 3
- [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Phase 2
- [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Phase 1
- Renal cell adenocarcinoma Phase 2
- [ST-elevation myocardial infarction](https://trialight.com/data/condition/st-elevation-myocardial-infarction-4462ec3a-15ca-527b-a581-39887b4bda63.md) Phase 2
- [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Phase 3

### Other linked conditions (2)

- Hypercholesterolemia, familial, 1
- [Peripheral arterial disease](https://trialight.com/data/condition/peripheral-arterial-disease-660376f2-3d22-5c83-86ea-1d146307e09b.md)

### Targets (1)

- [PCSK9](https://trialight.com/data/target/pcsk9-8d1e28c2-2f47-5dc5-b51e-ccfdc60cfc75.md) Subtilisin/kexin type 9 inhibitor

---

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