Bromocriptine
Bromocriptine, Cycloset, Parlodel (bromocriptine) is a small molecule pharmaceutical. Bromocriptine was first approved as Parlodel on 1982-01-01. It is used to treat acromegaly, adenoma, amenorrhea, galactorrhea, and hyperprolactinemia amongst others in the USA. The pharmaceutical is active against D(3) dopamine receptor, D(4) dopamine receptor, and D(2) dopamine receptor. In addition, it is known to target 5-hydroxytryptamine receptor 2B, alpha-2B adrenergic receptor, 5-hydroxytryptamine receptor 1B, 5-hydroxytryptamine receptor 1D, D(1A) dopamine receptor, D(1B) dopamine receptor, 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 1A, 5-hydroxytryptamine receptor 2C, 5-hydroxytryptamine receptor 6, 5-hydroxytryptamine receptor 7, alpha-2A adrenergic receptor, and alpha-2C adrenergic receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Cycloset, Parlodel (generic drugs available since 1998-01-13)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bromocriptine mesylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PARLODEL | Validus Pharmaceuticals | N-017962 RX | 1982-01-01 | 2 products, RLD |
| CYCLOSET | VeroScience | N-020866 RX | 2009-05-05 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bromocriptine mesylate | ANDA | 2023-09-11 |
| cycloset | New Drug Application | 2020-11-30 |
| parlodel | New Drug Application | 2023-12-15 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Bromocriptine Mesylate, Cycloset, Veroscience | |||
| 8431155 | 2032-04-30 | DP | U-976 |
| 8613947 | 2032-04-30 | DP | U-976 |
| 9192576 | 2032-04-30 | DP | U-976 |
| 9522117 | 2032-04-30 | DP | U-976, U-1939 |
| 9700555 | 2032-04-30 | DP | U-2183, U-2184, U-2185, U-2186, U-2187, U-2188, U-2189, U-2190, U-2191, U-2192, U-2193, U-2194, U-2195, U-2196, U-2197, U-2198 |
| 9993474 | 2032-04-30 | U-2384, U-2385, U-2386, U-2387, U-2388, U-2389, U-2390, U-2391, U-2392, U-2393 | |
| 10688094 | 2032-04-30 | U-2870, U-2871, U-2872, U-2873, U-2874, U-2875, U-2876, U-2877, U-2878, U-2879, U-2880, U-2881, U-2882, U-2883, U-2884, U-2885, U-2886, U-2887, U-2888 | |
| 11000522 | 2032-04-30 | U-3119, U-3120, U-3121, U-3122 | |
| 8877708 | 2030-06-07 | DP | U-1706 |
| 9352025 | 2030-06-07 | U-2111, U-2112, U-2113, U-2114, U-2115, U-2116, U-2117, U-2118, U-2119 | |
| 9895422 | 2030-06-07 | U-2114, U-2116, U-2281, U-2282, U-2283, U-2284, U-2285, U-2286, U-2287 | |
| 10688155 | 2030-06-07 | U-2281, U-2890, U-2891, U-2892, U-2893, U-2894, U-2895, U-2896, U-2897, U-2898, U-2899, U-2900, U-2901, U-2902, U-2903, U-2904, U-2905, U-2906, U-2907, U-2908, U-2909, U-2910, U-2911, U-2912, U-2913, U-2914, U-2915, U-2916, U-2917, U-2918, U-2919, U-2920, U-2921, U-2922, U-2923, U-2924, U-2925, U-2926, U-2927, U-2928, U-2929, U-2930, U-2931, U-2932, U-2933, U-2934, U-2935, U-2936, U-2937 | |
| 7888310 | 2023-07-25 | U-1433 | |
| 8137992 | 2023-07-25 | U-1433 | |
| 8137993 | 2023-07-25 | U-1433 | |
| 8137994 | 2023-07-25 | U-1433 | |
ATC Codes
G: Genito urinary system and sex hormones
— G02: Other gynecologicals in atc
— G02C: Other gynecologicals in atc
— G02CB: Prolactine inhibitors
— G02CB01: Bromocriptine
N: Nervous system drugs
— N04: Anti-parkinson drugs
— N04B: Dopaminergic agents
— N04BC: Dopamine agonists
— N04BC01: Bromocriptine
HCPCS
No data
Clinical
Clinical Trials
49 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | 2 | 2 | 1 | 6 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | 3 | 2 | — | 5 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 1 | 1 | — | 2 |
| Prolactinoma | D015175 | HP_0006767 | — | — | — | — | 1 | 1 | 2 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | 1 | — | 1 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | — | — | 1 | — | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | 1 | — | 1 |
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | 1 | 1 | — | — | 3 |
| Ischemic stroke | D000083242 | — | — | 1 | 2 | 1 | — | — | 2 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | — | — | 1 | — | 1 | 2 |
| Hyperprolactinemia | D006966 | HP_0000870 | E22.1 | — | — | 1 | — | — | 1 |
| Vascular dementia | D015140 | — | F01 | — | 1 | 1 | — | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | 1 | 1 | — | — | 1 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | 1 | 1 | — | — | 1 |
| Overweight | D050177 | — | E66.3 | — | — | 1 | — | — | 1 |
| Feeding behavior | D005247 | — | — | — | — | 1 | — | — | 1 |
| Dilated cardiomyopathy | D002311 | HP_0001644 | I42.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian hyperstimulation syndrome | D016471 | — | — | — | 2 | — | — | — | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | — | — | 1 | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 1 | — | — | — | 1 |
| Brain injuries | D001930 | — | S06.9 | 1 | 1 | — | — | — | 1 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | 1 | — | — | — | 1 |
| Cerebral hemorrhage | D002543 | — | — | 1 | 1 | — | — | — | 1 |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | 1 | 1 | — | — | — | 1 |
| Subdural hematoma | D006408 | HP_0100309 | — | 1 | 1 | — | — | — | 1 |
| Fever | D005334 | HP_0001945 | R50.9 | 1 | 1 | — | — | — | 1 |
| Intellectual disability | D008607 | EFO_0003847 | F73 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | 1 | — | — | — | — | 1 |
| Adenomyosis | D062788 | EFO_1001757 | N80.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | — | 1 | 1 |
| Chronic pain | D059350 | HP_0012532 | — | — | — | — | — | 1 | 1 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | — | — | — | 1 | 1 |
| Parkinsonian disorders | D020734 | HP_0001300 | G20.C | — | — | — | — | 1 | 1 |
| Pituitary neoplasms | D010911 | — | — | — | — | — | — | 1 | 1 |
| Growth disorders | D006130 | — | — | — | — | — | — | 1 | 1 |
| Graves ophthalmopathy | D049970 | EFO_1001466 | — | — | — | — | — | 1 | 1 |
| Perceptual disorders | D010468 | — | R41.4 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Bromocriptine |
| INN | bromocriptine |
| Description | Bromocriptine is an indole alkaloid. It has a role as an antiparkinson drug, a hormone antagonist, a dopamine agonist and an antidyskinesia agent. It derives from a hydride of an ergotaman. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)C[C@H]1C(=O)N2CCC[C@H]2[C@]2(O)O[C@](NC(=O)[C@@H]3C=C4c5cccc6[nH]c(Br)c(c56)C[C@H]4N(C)C3)(C(C)C)C(=O)N12 |
Identifiers
| PDB | — |
| CAS-ID | 25614-03-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL493 |
| ChEBI ID | 3181 |
| PubChem CID | 31101 |
| DrugBank | DB01200 |
| UNII ID | 3A64E3G5ZO (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CYP3A4
CYP3A4
Organism
Homo sapiens
Gene name
CYP3A4
Gene synonyms
CYP3A3
NCBI Gene ID
Protein name
cytochrome P450 3A4
Protein synonyms
1,4-cineole 2-exo-monooxygenase, 1,8-cineole 2-exo-monooxygenase, Albendazole monooxygenase (sulfoxide-forming), Albendazole sulfoxidase, Cholesterol 25-hydroxylase, CYPIIIA3, CYPIIIA4, Cytochrome P450 3A3, Cytochrome P450 HLp, Cytochrome P450 NF-25, cytochrome P450, family 3, subfamily A, polypeptide 4, cytochrome P450, subfamily IIIA (niphedipine oxidase), polypeptide 3, cytochrome P450, subfamily IIIA (niphedipine oxidase), polypeptide 4, Cytochrome P450-PCN1, glucocorticoid-inducible P450, Nifedipine oxidase, P450-III, steroid inducible, Quinine 3-monooxygenase, taurochenodeoxycholate 6-alpha-hydroxylase
Uniprot ID
Mouse ortholog
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—
Variants
No data
Financial
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Estimated US medical usage
Bromocriptine
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,618 adverse events reported
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