Overview
Cabergoline, an ergot derivative, is a long-acting dopamine agonist and prolactin inhibitor. It is used to treat hyperprolactinemic disorders and Parkinsonian Syndrome. Cabergoline possesses potent agonist activity on dopamine D2 receptors.
Background
Cabergoline, an ergot derivative, is a long-acting dopamine agonist and prolactin inhibitor. It is used to treat hyperprolactinemic disorders and Parkinsonian Syndrome. Cabergoline possesses potent agonist activity on dopamine D2 receptors.
Indication
For the treatment of hyperprolactinemic disorders, either idiopathic or due to prolactinoma (prolactin-secreting adenomas). May also be used to manage symptoms of Parkinsonian Syndrome as monotherapy during initial symptomatic management or as an adjunct to levodopa therapy during advanced stages of disease.
Associated Conditions
- Hyperprolactinemia
- Idiopathic hyperprolactinemic disorder
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/29 | Not Applicable | Not yet recruiting | |||
2025/06/24 | Phase 4 | ENROLLING_BY_INVITATION | |||
2025/04/03 | Phase 2 | Not yet recruiting | |||
2024/08/19 | Phase 2 | Completed | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2023/11/08 | Phase 4 | Recruiting | |||
2023/09/08 | Phase 2 | ENROLLING_BY_INVITATION | |||
2023/08/08 | Phase 2 | Completed | Al-Rasheed University College | ||
2022/09/01 | Not Applicable | Completed | |||
2021/08/27 | Not Applicable | Completed | |||
2021/01/08 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-823 | ORAL | 0.5 mg in 1 1 | 6/17/2022 | |
| Teva Pharmaceuticals USA, Inc. | 0093-5420 | ORAL | 0.5 mg in 1 1 | 7/31/2020 | |
| Ingenus Pharmaceuticals, LLC | 50742-118 | ORAL | 0.5 mg in 1 1 | 1/31/2024 | |
| A-S Medication Solutions | 50090-3951 | ORAL | 0.5 mg in 1 1 | 11/12/2019 | |
| A-S Medication Solutions | 50090-6596 | ORAL | 0.5 mg in 1 1 | 6/17/2022 | |
| SOLA Pharmaceuticals, LLC | 70512-860 | ORAL | 0.5 mg in 1 1 | 5/15/2023 | |
| Greenstone LLC | 59762-1005 | ORAL | 0.5 mg in 1 1 | 11/28/2022 | |
| Mylan Pharmaceuticals Inc. | 59762-1005 | ORAL | 0.5 mg in 1 1 | 11/28/2022 | |
| A-S Medication Solutions | 50090-5834 | ORAL | 0.5 mg in 1 1 | 11/19/2019 | |
| A-S Medication Solutions | 50090-3157 | ORAL | 0.5 mg in 1 1 | 7/31/2020 |
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 |
|---|---|---|---|---|---|
| DOSTINEX TABLET 0.5 mg | SIN09545P | TABLET | 0.5 mg | 11/21/1997 |
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 |
|---|---|---|---|---|---|
| BERGOLINE cabergoline 2mg tablets bottle | 132563 | Medicine | A | 4/7/2008 | |
| CABERGOLINE APOTEX cabergoline 500 micrograms tablets bottle | 218127 | Medicine | A | 11/20/2015 | |
| DOSTINEX cabergoline 0.5mg tablet bottle | 52158 | Medicine | A | 4/21/1995 | |
| CABASER Cabergoline 1mg tablet bottle | 57360 | Medicine | A | 10/24/1996 | |
| CARBELIN cabergoline 0.5 mg tablet bottle | 423450 | Medicine | A | 9/6/2024 | |
| TINEXA cabergoline 0.5mg tablets bottle | 132561 | Medicine | A | 4/7/2008 | |
| BERGOLINE cabergoline 1mg tablets bottle | 132562 | Medicine | A | 4/7/2008 | |
| CABASER Cabergoline 2mg tablet bottle | 57367 | Medicine | A | 10/24/1996 | |
| GenRx Cabergoline cabergoline 500 micrograms tablets bottle | 218128 | Medicine | A | 11/20/2015 | |
| DOSTAMINE cabergoline 0.5 mg tablet bottle | 423451 | Medicine | A | 9/6/2024 |