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.
Background
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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/04/12 | Phase 1 | Completed | |||
2017/12/27 | Phase 1 | Withdrawn | Andrew Moshfeghi, MD, MBA | ||
2016/10/11 | Phase 4 | Withdrawn | |||
2016/07/27 | Phase 2 | UNKNOWN | Sun Yat-sen University | ||
2016/02/17 | Phase 4 | Completed | |||
2015/10/29 | Phase 3 | Withdrawn | Montreal Heart Institute | ||
2015/09/09 | Phase 2 | Completed | |||
2015/04/29 | Not Applicable | Completed | |||
2015/04/29 | Not Applicable | Completed | |||
2014/11/24 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Validus Pharmaceuticals LLC | 30698-202 | ORAL | 2.5 mg in 1 1 | 12/12/2023 | |
| Sun Pharmaceutical Industries, Inc. | 63304-158 | ORAL | 5 mg in 1 1 | 2/6/2020 | |
| Sun Pharmaceutical Industries, Inc. | 63304-962 | ORAL | 2.5 mg in 1 1 | 2/6/2020 | |
| Physicians Total Care, Inc. | 54868-5667 | ORAL | 2.5 mg in 1 1 | 5/1/2012 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||