Overview
A synthetic hormone with anabolic and androgenic properties.
Indication
Use to promote weight gain after weight loss following extensive surgery.
Associated Conditions
- Amino acid catabolism disorder
- Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/16 | Phase 2 | Not yet recruiting | |||
2023/06/07 | Phase 4 | Suspended | George F. Hatch | ||
2022/08/26 | Phase 3 | Withdrawn | |||
2019/09/16 | Phase 1 | Terminated | Carelon Research | ||
2017/07/14 | Phase 1 | Completed | |||
2017/03/27 | Not Applicable | Active, not recruiting | |||
2014/01/28 | Phase 2 | Withdrawn | |||
2010/01/13 | Phase 1 | Completed | |||
2008/05/12 | Phase 2 | Terminated | |||
2008/05/07 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Upsher-Smith Laboratories, LLC | 0245-0271 | ORAL | 2.5 mg in 1 1 | 7/1/2020 | |
| Bryant Ranch Prepack | 63629-7603 | ORAL | 2.5 mg in 1 1 | 5/6/2022 | |
| Upsher-Smith Laboratories, LLC | 0245-0272 | ORAL | 10 mg in 1 1 | 7/1/2020 | |
| Par Pharmaceutical, Inc. | 49884-302 | ORAL | 10 mg in 1 1 | 7/5/2023 | |
| Par Pharmaceutical, Inc. | 49884-301 | ORAL | 2.5 mg in 1 1 | 7/5/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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