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Dostinex
Dostinex is a Small molecule drug developed by Par Pharmaceutical, Inc.. It is currently in Phase 1 development for Hyperprolactinemia, Prevention of ovarian hyperstimulation syndrome. Also known as: Cabergoline.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Dostinex |
|---|---|
| Also known as | Cabergoline |
| Sponsor | Par Pharmaceutical, Inc. |
| Target | D(1B) dopamine receptor, D(4) dopamine receptor, 5-hydroxytryptamine receptor 1A |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
- Hyperprolactinemia
- Prevention of ovarian hyperstimulation syndrome
Common side effects
- Nasopharyngitis
- Back pain
- Hypertension
- Hyperglycaemia
- Headache
- Covid-19
- Urinary tract infection
- Influenza
- Diabetes mellitus
- Diarrhoea
- Blood prolactin abnormal
- Aspartate aminotransferase increased
Key clinical trials
- Cabergoline for the Treatment of Chronic Pain Due to Endometriosis (PHASE2)
- A Reduced Dose of Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss (PHASE2)
- Cabergoline for Episodic Migraine (PHASE2)
- Cabergoline in the Management of Nonfunctioning Pituitary Adenoma (PHASE4)
- Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas (PHASE3)
- Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin (NA)
- Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies (PHASE4)
- Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Loss (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 |
|---|---|
| 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
- Par Pharmaceutical, Inc. portfolio CI
Frequently asked questions about Dostinex
What is Dostinex?
What is Dostinex used for?
Who makes Dostinex?
Is Dostinex also known as anything else?
What development phase is Dostinex in?
What are the side effects of Dostinex?
What does Dostinex target?
Related
- Target: All drugs targeting D(1B) dopamine receptor, D(4) dopamine receptor, 5-hydroxytryptamine receptor 1A
- Manufacturer: Par Pharmaceutical, Inc. — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Hyperprolactinemia
- Indication: Drugs for Prevention of ovarian hyperstimulation syndrome
- Also known as: Cabergoline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing