Overview
Pegvisomant is a highly selective growth hormone (GH) receptor antagonist. It is used to treat acromegaly. Unlike dopamine or somatostatin analogs (which inhibit growth hormone secretion), this drug actually blocks the hepatic (GH-mediated) production of insulin like growth factor (IGF-1), which is the main mediator of growth hormone activity.
Background
Pegvisomant is a highly selective growth hormone (GH) receptor antagonist. It is used to treat acromegaly. Unlike dopamine or somatostatin analogs (which inhibit growth hormone secretion), this drug actually blocks the hepatic (GH-mediated) production of insulin like growth factor (IGF-1), which is the main mediator of growth hormone activity.
Indication
Pegvisomant is a growth hormone receptor antagonist used for the treatment of acromegaly.
Associated Conditions
- Acromegaly
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/07/22 | Phase 2 | Recruiting | |||
2021/11/23 | N/A | Recruiting | |||
2019/03/20 | Phase 3 | Active, not recruiting | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||
2017/07/21 | N/A | Completed | |||
2016/11/02 | Phase 3 | Completed | |||
2016/01/29 | Phase 4 | UNKNOWN | |||
2015/07/16 | Not Applicable | Completed | |||
2013/12/30 | Phase 2 | Completed | |||
2013/07/09 | Phase 1 | Completed | |||
2013/03/05 | Not Applicable | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/12/2002 | ||
Authorised | 11/12/2002 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SOMAVERT pegvisomant (rbe) 10mg powder for injection vial and diluent in pre-filled syringe | 286628 | Medicine | A | 5/31/2017 | |
| SOMAVERT pegvisomant (rbe) 15mg powder for injection vial and diluent in pre-filled syringe | 286629 | Medicine | A | 5/31/2017 | |
| SOMAVERT pegvisomant (rbe) 20mg powder for injection vial and diluent in pre-filled syringe | 286630 | Medicine | A | 5/31/2017 |