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Bromocriptine | CAS No: 25614-03-3 | GMP-certified suppliers
A medication that addresses hyperprolactinemia-related disorders, supports management of Parkinsonian symptoms, and serves as adjunct therapy for select patients with acromegaly.
Therapeutic categories
Primary indications
- 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
Product Snapshot
- Oral small‑molecule API available in multiple tablet and capsule presentations
- Used for prolactin‑related endocrine disorders, acromegaly adjunct therapy, and Parkinson’s disease management, with additional off‑label neurological applications
- Marketed in the US and Canada with a mix of approved, investigational, and withdrawn statuses depending on product form and indication
Clinical Overview
Bromocriptine acts primarily as a dopamine D2 receptor agonist with activity at D3 receptors and lower‑affinity interactions across several serotonergic and adrenergic receptor subtypes. Its antiparkinsonian effect is linked to postsynaptic D2 stimulation within the nigrostriatal pathway, improving motor coordination in the context of dopaminergic deficit. In the tuberoinfundibular pathway, D2 activation suppresses prolactin secretion, forming the basis for its efficacy in hyperprolactinemic disorders. In acromegaly, bromocriptine reduces somatotropin secretion in some patients. Receptor interactions at 5‑HT1B and 5‑HT2B have been associated with reports of pulmonary fibrosis.
Mechanistically, D2 receptor activation reduces intracellular cAMP, inhibits IP3‑mediated calcium release, and decreases calcium influx, contributing to suppression of prolactin release and modulation of growth hormone output. Signal transduction effects include inhibition of MAPK and ERK kinase pathways via Raf‑dependent mechanisms.
Bromocriptine is metabolized primarily by CYP3A pathways and is both a substrate and inhibitor of CYP3A4. It also interacts with P‑glycoprotein transport systems. Reported adverse effects include nausea, orthostatic hypotension, hallucinations, impulse‑control symptoms, and rare fibrotic complications.
Relevant brands include formulations of bromocriptine mesylate commonly used worldwide for endocrine and neurologic indications. For API procurement, suppliers should ensure control of ergot‑related impurities, confirmation of stereochemical integrity, and compliance with pharmacopeial specifications and regional GMP standards.
Identification & chemistry
| Generic name | Bromocriptine |
|---|---|
| Molecule type | Small molecule |
| CAS | 25614-03-3 |
| UNII | 3A64E3G5ZO |
| DrugBank ID | DB01200 |
Pharmacology
| Summary | Bromocriptine is a dopamine D2‑selective agonist that modulates G‑protein signaling to reduce intracellular cAMP and calcium flux, leading to inhibition of prolactin release and support of dopaminergic activity in motor pathways. Its pharmacodynamic profile is dominated by D2 and D3 receptor engagement, with additional interactions across serotonergic and adrenergic receptors that contribute to both therapeutic and off‑target effects. These actions underpin its use in conditions involving prolactin excess and dopaminergic pathway dysfunction. |
|---|---|
| Mechanism of action | The dopamine D<sub>2</sub> receptor is a 7-transmembrane G-protein coupled receptor associated with G<sub>i</sub> proteins. In lactotrophs, stimulation of dopamine D<sub>2</sub> receptor causes inhibition of adenylyl cyclase, which decreases intracellular cAMP concentrations and blocks IP3-dependent release of Ca<sup>2+</sup> from intracellular stores. Decreases in intracellular calcium levels may also be brought about via inhibition of calcium influx through voltage-gated calcium channels, rather than via inhibition of adenylyl cyclase. Additionally, receptor activation blocks phosphorylation of p42/p44 MAPK and decreases MAPK/ERK kinase phosphorylation. Inhibition of MAPK appears to be mediated by c-Raf and B-Raf-dependent inhibition of MAPK/ERK kinase. Dopamine-stimulated growth hormone release from the pituitary gland is mediated by a decrease in intracellular calcium influx through voltage-gated calcium channels rather than via adenylyl cyclase inhibition. Stimulation of dopamine D<sub>2</sub> receptors in the nigrostriatal pathway leads to improvements in coordinated muscle activity in those with movement disorders. |
| Pharmacodynamics | Bromocriptine stimulates centrally-located dopaminergic receptors resulting in a number of pharmacologic effects. Five dopamine receptor types from two dopaminergic subfamilies have been identified. The dopaminergic D1 receptor subfamily consists of D<sub>1</sub> and D<sub>5</sub> subreceptors, which are associated with dyskinesias. The dopaminergic D2 receptor subfamily consists of D<sub>2</sub>, D<sub>3</sub> and D<sub>4</sub> subreceptors, which are associated with improvement of symptoms of movement disorders. Thus, agonist activity specific for D2 subfamily receptors, primarily D<sub>2</sub> and D<sub>3</sub> receptor subtypes, are the primary targets of dopaminergic antiparkinsonian agents. It is thought that postsynaptic D<sub>2</sub> stimulation is primarily responsible for the antiparkinsonian effect of dopamine agonists, while presynaptic D<sub>2</sub> stimulation confers neuroprotective effects. This semisynthetic ergot derivative exhibits potent agonist activity on dopamine D<sub>2</sub>-receptors. It also exhibits agonist activity (in order of decreasing binding affinity) on 5-hydroxytryptamine (5-HT)<sub>1D</sub>, dopamine D<sub>3</sub>, 5-HT<sub>1A</sub>, 5-HT<sub>2A</sub>, 5-HT<sub>1B</sub>, and 5-HT<sub>2C</sub> receptors, antagonist activity on α<sub>2A</sub>-adrenergic, α<sub>2C</sub>, α<sub>2B</sub>, and dopamine D<sub>1</sub> receptors, partial agonist activity at receptor 5-HT<sub>2B</sub>, and inactivates dopamine D<sub>4</sub> and 5-HT<sub>7</sub> receptors. Parkinsonian Syndrome manifests when approximately 80% of dopaminergic activity in the nigrostriatal pathway of the brain is lost. As this striatum is involved in modulating the intensity of coordinated muscle activity (e.g. movement, balance, walking), loss of activity may result in dystonia (acute muscle contraction), Parkinsonism (including symptoms of bradykinesia, tremor, rigidity, and flattened affect), akathesia (inner restlessness), tardive dyskinesia (involuntary muscle movements usually associated with long-term loss of dopaminergic activity), and neuroleptic malignant syndrome, which manifests when complete blockage of nigrostriatal dopamine occurs. High dopaminergic activity in the mesolimbic pathway of the brain causes hallucinations and delusions; these side effects of dopamine agonists are manifestations seen in patients with schizophrenia who have overractivity in this area of the brain. The hallucinogenic side effects of dopamine agonists may also be due to 5-HT<sub>2A</sub> agonism. The tuberoinfundibular pathway of the brain originates in the hypothalamus and terminates in the pituitary gland. In this pathway, dopamine inhibits lactotrophs in anterior pituitary from secreting prolactin. Increased dopaminergic activity in the tuberoinfundibular pathway inhibits prolactin secretion making bromocriptine an effective agent for treating disorders associated with hypersecretion of prolactin. Pulmonary fibrosis may be associated bromocriptine’s agonist activity at 5-HT<sub>1B</sub> and 5-HT<sub>2B</sub> receptors. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Dopamine D2 receptor | Humans | agonist |
| Dopamine D3 receptor | Humans | agonist |
| 5-hydroxytryptamine receptor 1D | Humans | agonist |
ADME / PK
| Absorption | Approximately 28% of the oral dose is absorbed; however due to a substantial first pass effect, only 6% of the oral dose reaches the systemic circulation unchanged. Bromocriptine and its metabolites appear in the blood as early as 10 minutes following oral administration and peak plasma concentration are reached within 1-1.5 hours. Serum prolactin may be decreased within 2 hours or oral administration with a maximal effect achieved after 8 hours. Growth hormone concentrations in patients with acromegaly is reduced within 1-2 hours with a single oral dose of 2.5 mg and decreased growth hormone concentrations persist for at least 4-5 hours. |
|---|---|
| Half-life | 2-8 hours |
| Protein binding | 90-96% bound to serum albumin |
| Metabolism | Completely metabolized by the liver, primarily by hydrolysis of the amide bond to produce lysergic acid and a peptide fragment, both inactive and non-toxic. Bromocriptine is metabolized by cytochrome P450 3A4 and excreted primarily in the feces via biliary secretion. |
| Route of elimination | Parent drug and metabolites are almost completely excreted via the liver, and only 6% eliminated via the kidney. |
Formulation & handling
- Oral small‑molecule lysergamide with low aqueous solubility, requiring solubility‑enhancing or dispersion approaches for consistent dissolution.
- Solid‑state API is lipophilic (LogP ~3.9), supporting use of lipidic or controlled‑release matrices to manage absorption variability.
- Typically administered with food to reduce gastric irritation, so formulations may consider GI tolerability and robustness to fed‑state conditions.
Regulatory status
| Lifecycle | Most legacy U.S. patents for the API expired between 2012 and 2015, with an additional secondary patent expiring in 2023, while remaining protections extend to 2032, indicating mixed maturity. With commercialization limited to the U.S. and Canada, the market shows partial generic exposure but retains some patent-based exclusivity through the early 2030s. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Bromocriptine is supplied by a large number of manufacturers and repackagers, indicating a well‑established generic supply base alongside the original developer. Branded and generic products are available in major regulated markets, including the United States and Canada. While several older U.S. patents have expired, allowing broad generic competition, later patents extending into 2032 suggest that certain protected formulations or uses may still limit full generic entry in specific segments. |
|---|
Safety
| Toxicity | Symptoms of overdosage include nausea, vomiting, and severe hypotension. The most common adverse effects include nausea, headache, vertigo, constipation, light-headedness, abdominal cramps, nasal congestion, diarrhea, and hypotension. |
|---|
- Overexposure may elicit pronounced gastrointestinal distress (nausea, vomiting) and marked decreases in blood pressure, requiring controls to limit acute hypotensive events during handling
- Routine handling should account for CNS‑active effects such as headache, vertigo, and light‑headedness, which indicate the compound’s potential to affect vestibular and autonomic pathways
- Material management should consider its propensity to cause abdominal cramping, constipation or diarrhea, reflecting broad smooth‑muscle and dopaminergic activity relevant to occupational exposure assessment
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Bromocriptine is a type of Dopamine agonists
Dopamine agonists are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that act on the dopamine receptors in the brain. These compounds mimic the effects of dopamine, a neurotransmitter involved in various physiological processes such as movement, cognition, and emotions.
Dopamine agonists are commonly used in the treatment of neurological disorders, particularly Parkinson's disease and restless legs syndrome. They work by binding to dopamine receptors and stimulating them, thereby increasing dopamine activity in the brain. This helps to alleviate the symptoms associated with these conditions, such as tremors, rigidity, and muscle stiffness.
One of the key advantages of dopamine agonists is their ability to provide long-lasting relief compared to other medications. They are available in different formulations, including oral tablets, transdermal patches, and injectable solutions, allowing patients to choose the most suitable administration method.
However, like any medication, dopamine agonists may have side effects. These can include nausea, dizziness, hallucinations, and compulsive behaviors. It is important for healthcare professionals to closely monitor patients using dopamine agonists to minimize the occurrence and severity of these side effects.
In conclusion, dopamine agonists are a vital subcategory of pharmaceutical APIs used to manage Parkinson's disease and restless legs syndrome. They mimic the effects of dopamine in the brain and offer long-lasting relief from symptoms. Although they can have side effects, proper monitoring and dosage adjustments can help optimize their therapeutic benefits.
Bromocriptine (Dopamine agonists), classified under Central Nervous System Agents
Central Nervous System (CNS) Agents are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that specifically target the central nervous system. The CNS encompasses the brain and spinal cord, playing a vital role in regulating and controlling various bodily functions, including cognition, movement, emotions, and sensory perception. These agents are designed to interact with specific receptors, enzymes, or ion channels within the CNS to modulate neural activity and restore normal functioning.
CNS agents comprise a diverse range of pharmaceutical APIs, including analgesics, anesthetics, antipsychotics, sedatives, hypnotics, anti-epileptics, and antidepressants. Each subcategory addresses distinct neurological disorders and conditions. For instance, analgesics alleviate pain by targeting receptors in the brain and spinal cord, while antipsychotics are employed to manage psychosis symptoms in mental illnesses such as schizophrenia.
The development of CNS agents involves rigorous research, molecular modeling, and extensive clinical trials to ensure safety, efficacy, and specific target engagement. Pharmaceutical companies invest significant resources in identifying novel drug targets, synthesizing new compounds, and optimizing their pharmacological properties. These agents undergo rigorous regulatory evaluations and must adhere to stringent quality standards and guidelines.
Given the prevalence of CNS disorders globally, the market demand for effective CNS agents is substantial. The development of innovative CNS APIs not only improves patient outcomes but also provides valuable commercial opportunities for pharmaceutical companies. Continued advancements in CNS agent research and development hold the promise of groundbreaking therapies that can improve the quality of life for individuals affected by neurological conditions.
Bromocriptine API manufacturers & distributors
Compare qualified Bromocriptine API suppliers worldwide. We currently have 5 companies offering Bromocriptine API, with manufacturing taking place in 4 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Aquatic Remedies Pvt Ltd | Producer | India | India | CoA | 35 products |
| Curia | Producer | United States | Italy | CEP, CoA, GMP, MSDS, USDMF | 106 products |
| Euticals | Producer | Italy | Unknown | CEP, CoA, FDA, GMP, USDMF | 48 products |
| Lek Pharma | Producer | Slovenia | Unknown | CoA, JDMF, USDMF | 32 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
When sending a request, specify which Bromocriptine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Bromocriptine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Bromocriptine API
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