Romosozumab

Highest phase reached

Approved

www.ebi.ac.uk

Drug type

Antibody

www.ebi.ac.uk

First approval year

2019

www.ebi.ac.uk

First approval year: 2019
www.ebi.ac.uk

Listing at source: Listed

Highest phase reached: Approved
www.ebi.ac.uk

Drug type: Antibody
www.ebi.ac.uk

Drug name: Romosozumab
www.ebi.ac.uk

evenity
Evenity

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.

CAS registry numbers

909395-70-6

ChEMBL ID: CHEMBL2107874
www.ebi.ac.uk

FDA ingredient codes (UNII)

3VHF2ZD92J

M05BX
M05BX06

Sources for recorded values

www.ebi.ac.uk

2123126
2123180

Applicant: AMGEN INC
Approval date: 9 Apr 2019
Application number: BLA761062

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

www.ema.europa.eu

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

United States (FDA): Approved
European Union (EMA): Authorised

Pharmacology name: romosozumab
Type: Antibody
Drug name stem: -mab; -mab
Approval recorded by Guide to Pharmacology: Yes

Administration routes

Parenteral

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

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

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

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

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

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.

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Dose: 210 mg
Route: Subcutaneous
How often: Once every month for 12 doses

Administer by healthcare provider
Inject two separate syringes, one after the other

Prodrug: No
Chirality: Single enantiomer
Inorganic: No
Natural product: No

Component
Light chain
Type
Protein
Sequence
DIQMTQSPSSLSASVGDRVTITCRASQDISNYLNWYQQKPGKAPKLLIYYTSRLLSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQGDTLPYTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Component
Heavy chain
Type
Protein
Sequence
EVQLVQSGAEVKKPGASVKVSCKASGYTFTDYNMHWVRQAPGQGLEWMGEINPNSGGAGYNQKFKGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARLGYDDIYDDWYFDVWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGKEYKCKVSNKGLPAPIEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK

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
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
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 Sclerostin inhibitor

Romosozumab

Development status

Names and chemistry

Brand names (2)

Other names (26)

Identifiers

ATC classification codes (2)

RxNorm IDs (RxCUI) (2)

Regulatory information

United States

European Union

Therapeutic areas

Other regulatory facts

Approval status

Pharmacology

Drug classification

Administration routes

Mechanisms of action (2)

Open Targets mechanisms

Investigated indications (6)

Open Targets indications (14)

Warnings (4)

Open Targets warnings (4)

Reported adverse events (31)

Trial references (23)

Dosing

Conditions of use (2)

Chemical properties

Sequences (2)

National Drug Codes

Related records

Trials (44)

Approved for (3)

In development for (6)

Targets (1)