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Dostinex (CABERGOLINE)
Dostinex (CABERGOLINE) is a small molecule ergot derivative that targets the D(2) dopamine receptor. It is used to treat hyperprolactinemia and prevent ovarian hyperstimulation syndrome. Originally developed by Pfizer Japan Inc., it is now owned by Pfizer and has been FDA-approved since 1996. Dostinex is available as a generic medication, with multiple manufacturers, and is no longer patented. As an ergot derivative, it has a relatively long half-life of 60 hours and moderate bioavailability of 65%.
At a glance
| Generic name | CABERGOLINE |
|---|---|
| Sponsor | Pfizer Japan Inc. |
| Drug class | Ergot Derivative [EPC] |
| Target | D(2) dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
- Hyperprolactinemia
- Prevention of ovarian hyperstimulation syndrome
Common side effects
- Nausea
- Headache
- Dizziness
- Constipation
- Abdominal pain
- Vomiting
- Asthenia
- Fatigue
- Dyspepsia
- Somnolence
- Depression
- Hot flashes
Drug interactions
- clarithromycin
- conivaptan
- mibefradil
- nefazodone
Key clinical trials
- Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms (PHASE2)
- Safety and Potency of a High Cabergoline Dosage in Microprolactinomas (PHASE3)
- Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome (PHASE2)
- Carbergoline for Antipsychotic Induced Hyperprolactinemia. (PHASE4)
- Cabergoline for the Treatment of Chronic Pain Due to Endometriosis (PHASE2)
- Cabergoline & Letrozole Versus Letrozole in Ovulation Induction in PCOS (NA)
- A Reduced Dose of Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss (PHASE2)
- Cabergoline for Episodic Migraine (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dostinex CI brief — competitive landscape report
- Dostinex updates RSS · CI watch RSS
- Pfizer Japan Inc. portfolio CI