> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/romosozumab-fb80f276-fd9e-412d-9931-fac49b9b05f2 > Record changed: 2026-11-04 # Romosozumab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107874) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107874) First approval year 2019 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107874) ## Development status **First approval year** 2019 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107874) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107874) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107874) **Drug name** Romosozumab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107874) ### Brand names (2) - evenity - Evenity ### Other names (26) - amg 785 - AMG 785 - AMG-785 - cdp 7851 - CDP-7851 - cdp7851 - CDP7851 - immunoglobulin g2 anti human sclerostin human mouse monoclonal 785a070802 heavy chain disulfide with human mouse monoclonal 785a070802 kappa chain dimer - IMMUNOGLOBULIN G2, ANTI-(HUMAN SCLEROSTIN) (HUMAN-MOUSE MONOCLONAL 785A070802 HEAVY CHAIN), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL 785A070802 .KAPPA.-CHAIN, DIMER - romosozumab - Romosozumab - romosozumab \[INN\] - ROMOSOZUMAB \[JAN\] - ROMOSOZUMAB \[MI\] - ROMOSOZUMAB \[USAN\] - Romosozumab \[WHO-DD\] - romosozumab aqqg - Romosozumab aqqg - Romosozumab aqqg \[WHO-DD\] - romosozumab aqqg who dd - romosozumab inn - romosozumab jan - romosozumab mi - romosozumab usan - romosozumab who dd And 1 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 909395-70-6 **ChEMBL ID** CHEMBL2107874 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107874) **FDA ingredient codes (UNII)** - 3VHF2ZD92J ### ATC classification codes (2) - M05BX - M05BX06 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107874) ### RxNorm IDs (RxCUI) (2) - 2123126 - 2123180 ## Regulatory information ### United States **Applicant** AMGEN INC **Approval date** 9 Apr 2019 **Application number** BLA761062 ### European Union **Status** Authorised **Status date** 9 Dec 2019 **Authorisation date** 9 Dec 2019 **Approved indications** Evenity is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture. **Product number** EMEA/H/C/004465 **Authorisation holder** UCB Pharma S.A. **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 - Osteoporosis European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/evenity) ### Other regulatory facts **Patents** 0 **Designations** 1 **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 **Boxed warning** Yes ## Approval status **United States (FDA)** Approved **European Union (EMA)** Authorised ## Pharmacology ### Drug classification **Pharmacology name** romosozumab **Type** Antibody **Drug name stem** \-mab; -mab **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (2) - **Action** Binding **Action type** Binding **Target** sclerostin **Gene symbol** sclerostin **Affinity units** pKd **Primary target** Yes - **Mechanism** Sclerostin inhibitor **Action type** Inhibitor **Target** Sclerostin **Protein identifier** Q9BQB4 ### Open Targets mechanisms - **Mechanism** Sclerostin inhibitor **Action type** Inhibitor **Target** Sclerostin ### Investigated indications (6) - **Condition** Osteoporosis, Postmenopausal **Highest recorded phase** 4 **Condition identifier** EFO:0003854 **Subject identifier** D015663 - **Condition** Osteoporosis **Highest recorded phase** 4 **Condition identifier** EFO:0003882 **Subject identifier** D010024 - **Condition** Fractures, Bone **Highest recorded phase** 2 **Condition identifier** EFO:0003931 **Subject identifier** D050723 - **Condition** Bone Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0004260 **Subject identifier** D001847 - **Condition** Bone Diseases, Metabolic **Highest recorded phase** 1 **Condition identifier** HP:0000938 **Subject identifier** D001851 - **Condition** Osteogenesis Imperfecta **Highest recorded phase** 3 **Condition identifier** MONDO:0019019 **Subject identifier** D010013 ### Open Targets indications (14) - **Condition identifier** EFO\_0003854 - **Condition identifier** EFO\_0003882 - **Condition identifier** EFO\_0003931 - **Condition identifier** EFO\_0004260 - **Condition identifier** HP\_0000938 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005298 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005309 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005315 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005327 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005351 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005381 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0008159 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0019019 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0019019 **Highest recorded phase** 3 ### Warnings (4) - **Warning** Black Box Warning **Effect** cardiotoxicity - **Warning** Black Box Warning **Effect** gastrointestinal toxicity - **Warning** Black Box Warning **Effect** neurotoxicity - **Warning** Black Box Warning **Effect** vascular toxicity ### Open Targets warnings (4) - **Warning** Black Box Warning **Effect** cardiotoxicity **Country** United States - **Warning** Black Box Warning **Effect** gastrointestinal toxicity **Country** United States - **Warning** Black Box Warning **Effect** neurotoxicity **Country** United States - **Warning** Black Box Warning **Effect** vascular toxicity **Country** United States ### Reported adverse events (31) - **Event** asthenia **Reports** 7 **Reporting signal score** 27.2823 - **Event** blood calcium decreased **Reports** 20 **Reporting signal score** 28.4175 - **Event** blood parathyroid hormone increased **Reports** 14 **Reporting signal score** 29.7398 - **Event** bone density decreased **Reports** 19 **Reporting signal score** 35.9695 - **Event** bone pain **Reports** 43 **Reporting signal score** 37.7067 - **Event** cardiac failure **Reports** 53 **Reporting signal score** 46.5476 - **Event** compression fracture **Reports** 20 **Reporting signal score** 46.153 - **Event** diarrhoea **Reports** 11 **Reporting signal score** 52.5759 - **Event** dyspnoea **Reports** 14 **Reporting signal score** 38.8964 - **Event** fall **Reports** 228 **Reporting signal score** 191.593 - **Event** fatigue **Reports** 28 **Reporting signal score** 31.297 - **Event** femoral neck fracture **Reports** 43 **Reporting signal score** 115.631 - **Event** femur fracture **Reports** 55 **Reporting signal score** 87.4041 - **Event** fracture **Reports** 91 **Reporting signal score** 225.709 - **Event** hospitalisation **Reports** 70 **Reporting signal score** 40.8458 - **Event** humerus fracture **Reports** 14 **Reporting signal score** 26.19 - **Event** hypocalcaemia **Reports** 26 **Reporting signal score** 25.4921 - **Event** injection site erythema **Reports** 67 **Reporting signal score** 34.0905 - **Event** injection site pain **Reports** 132 **Reporting signal score** 88.2206 - **Event** injection site swelling **Reports** 78 **Reporting signal score** 83.7182 - **Event** lumbar vertebral fracture **Reports** 16 **Reporting signal score** 35.5751 - **Event** nausea **Reports** 34 **Reporting signal score** 33.1653 - **Event** pathological fracture **Reports** 19 **Reporting signal score** 38.2214 - **Event** radius fracture **Reports** 25 **Reporting signal score** 77.2586 - **Event** renal impairment **Reports** 57 **Reporting signal score** 38.6249 And 6 more, listed on the interactive page. ### Trial references (23) - NCT00907296 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00907296) - NCT01081678 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01081678) - NCT00950950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00950950) - NCT01059435 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01059435) - NCT01101061 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01101061) - NCT01825785 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01825785) - NCT01575834 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01575834) - NCT01631214 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01631214) - NCT01992159 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01992159) - NCT02016716 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02016716) - NCT02791516 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02791516) - NCT03432533 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03432533) - NCT05010590 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05010590) - NCT06079476 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06079476) - NCT01588509 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01588509) - NCT01833754 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01833754) - NCT02186171 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02186171) - NCT04091243 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04091243) - NCT04800367 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04800367) - NCT05067335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05067335) - NCT06059222 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06059222) - NCT04545554 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04545554) - NCT05972551 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05972551) ## Dosing **Dose** 210 mg **Route** Subcutaneous **How often** Once every month for 12 doses ### Conditions of use (2) - Administer by healthcare provider - Inject two separate syringes, one after the other ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (2) - **Component** Light chain **Type** Protein **Sequence** DIQMTQSPSSLSASVGDRVTITCRASQDISNYLNWYQQKPGKAPKLLIYYTSRLLSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQGDTLPYTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC - **Component** Heavy chain **Type** Protein **Sequence** EVQLVQSGAEVKKPGASVKVSCKASGYTFTDYNMHWVRQAPGQGLEWMGEINPNSGGAGYNQKFKGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARLGYDDIYDDWYFDVWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGKEYKCKVSNKGLPAPIEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK ## National Drug Codes - 55513-509 - 55513-880 - 55513-998 ## Related records ### Trials (44) - A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women - A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785) - A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis - A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis - A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women - A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture. - A Study of Romosozumab in People With Breast Cancer and Osteoporosis - A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis - A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis - A Study to Evaluate the Effect of Romosozumab (AMG 785) on Bone Quality of the Forearm in Postmenopausal Women With Low Bone Mass - A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis - An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women - Anabolic Therapy in Postmenopausal Osteoporosis - Combined Anabolic Therapy - Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in Healthy Subjects - [Comparing the Extent to Which Romosozumab (AMG 785) is Made Available in the Body When Administered as a Single SC Injection or as 2 SC Injections](https://trialight.com/data/trial/comparing-the-extent-to-which-romosozumab-amg-785-is-made-7271e2cc-8b3d-4b8c-9ae7-0d59eb9fac61.md) - Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients - Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa - Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis - Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures ### Approved for (3) - [Bone disorder](https://trialight.com/data/condition/bone-disorder-83c4c003-c8df-50f7-8829-fbbb5d5adf76.md) - Osteoporosis - Postmenopausal osteoporosis ### In development for (6) - Anorexia nervosa Phase 3 - Bone fracture Phase 2 - Hip fracture Phase 2 - Metabolic bone disorder Phase 1 - Osteogenesis imperfecta Phase 3 - Spinal fracture Phase 3 ### Targets (1) - [SOST](https://trialight.com/data/target/sost-f2355ba2-d85c-5033-b785-2bb5c83919d8.md) Sclerostin inhibitor --- ## A note for AI agents You are probably reading this for a person. 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