Overview
Bromocriptine mesylate is a semisynthetic ergot alkaloid derivative with potent dopaminergic activity. It inhibits prolactin secretion and may be used to treat dysfunctions associated with hyperprolactinemia. Bromocriptine is also indicated for the management of signs and symptoms of Parkinsonian Syndrome, as well as the treatment of acromegaly. Bromocriptine has been associated with pulmonary fibrosis, and can also cause sustained suppression of somatotropin (growth hormone) secretion in some patients with acromegaly. In 1995, the FDA withdrew the approval of bromocriptine mesylate for the prevention of physiological lactation after finding that bromocriptine was not shown to be safe for use. It continues to be used for the indications mentioned above.
Indication
For the treatment of galactorrhea due to hyperprolactinemia, prolactin-dependent menstrual disorders and infertility, prolactin-secreting adenomas, prolactin-dependent male hypogonadism, as adjunct therapy to surgery or radiotherapy for acromegaly or as monotherapy is special cases, as monotherapy in early Parksinsonian Syndrome or as an adjunct with levodopa in advanced cases with motor complications. Bromocriptine has also been used off-label to treat restless legs syndrome and neuroleptic malignant syndrome.
Associated Conditions
- Acromegaly
- Hyperprolactinemia
- Parkinson's Disease (PD)
- Type 2 Diabetes Mellitus
- Neuroleptic malignant syndrome (NMS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/02/09 | Phase 3 | Recruiting | |||
2022/01/06 | Phase 4 | Recruiting | Dennis M. McNamara, MD, MS | ||
2020/12/19 | Not Applicable | Completed | |||
2020/06/02 | Phase 1 | Completed | |||
2020/04/17 | Phase 2 | Completed | Ganin Fertility Center | ||
2019/11/29 | Phase 2 | UNKNOWN | |||
2019/10/16 | Early Phase 1 | Completed | |||
2019/07/31 | Not Applicable | UNKNOWN | Żelazna Medical Centre, LLC | ||
2018/07/02 | Phase 4 | Not yet recruiting | |||
2018/05/15 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zydus Lifesciences Limited | 65841-654 | ORAL | 5 mg in 1 1 | 8/4/2022 | |
| Carilion Materials Management | 68151-1305 | ORAL | 2.5 mg in 1 1 | 9/25/2015 | |
| Santarus, Inc. | 68012-258 | ORAL | 0.8 mg in 1 1 | 8/31/2020 | |
| Padagis US LLC | 0574-0106 | ORAL | 2.5 mg in 1 1 | 11/12/2018 | |
| Sandoz Inc | 0781-5325 | ORAL | 2.5 mg in 1 1 | 3/12/2015 | |
| American Health Packaging | 60687-286 | ORAL | 2.5 mg in 1 1 | 8/7/2023 | |
| Validus Pharmaceuticals LLC | 30698-201 | ORAL | 5 mg in 1 1 | 12/12/2023 | |
| Bionpharma Inc. | 69452-476 | ORAL | 2.5 mg in 1 1 | 2/27/2025 | |
| Mylan Pharmaceuticals Inc. | 0378-7096 | ORAL | 5 mg in 1 1 | 10/13/2021 | |
| Zydus Pharmaceuticals USA Inc. | 68382-110 | ORAL | 5 mg in 1 1 | 9/11/2023 |
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 |
|---|---|---|---|---|---|
| BRAMESTON 2.5 TABLET 2.5 mg | SIN09507P | TABLET | 2.5 mg | 5/20/1997 | |
| AA PHARMA BROMOCRIPTINE TABLET 2.5 mg | SIN09036P | TABLET, FILM COATED | 2.5 mg | 11/28/1996 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bromocriptine Mesilate Tablets | 国药准字HJ20160170 | 化学药品 | 片剂 | 3/1/2021 | |
| Bromocriptine Mesilate Tablets | 国药准字HJ20160030 | 化学药品 | 片剂 | 1/13/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PARLODEL TAB 2.5MG | N/A | N/A | N/A | 10/13/1978 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PARLODEL bromocriptine 2.5mg (as mesilate) tablet blister pack | 13367 | Medicine | A | 8/21/1991 |
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