Data updated: Jul 17, 2026
DOSTINEX (cabergoline) · Pfizer
Trial Activity: Stable 7 active trials
Endocrine
Approved 1996-12-23
Development Insights
University of Sao Paulo General Hospital conducting 3 trials (18%)
30 indications explored (Broad Platform)
→ prolactinoma (2 trials)
→ prolactin excess (2 trials)
→ lactation suppressed (2 trials)
2
Indications
--
Phase 3 Trials
29
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1996-12-23
- Routes
- ORAL
- Dosage Forms
- TABLET
DOSTINEX Approval History
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
15 FDA actions from 1996 to 2025 · 1 indication expansions
Aug 2014 SUPPL
Mfg · Manufacturing (CMC)
May 2014 SUPPL
Mfg
Apr 2000 SUPPL
Label
May 1998 SUPPL
Mfg
Sep 1997 SUPPL
Mfg
Dec 1996 ORIGINAL
New Drug
What DOSTINEX Treats
2 FDA approvalsOriginally approved for its first indication in 1996 . Covers 2 distinct patient populations.
- Other (2)
Pfizer's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
HYMPAVZI
2024 MARSTACIMAB-HNCQ
2 designations
ZAVZPRET
2023 ZAVEGEPANT HYDROCHLORIDE
ELREXFIO
2023 ELRANATAMAB
5 designations
LITFULO
2023 RITLECITINIB TOSYLATE
PAXLOVID (COPACKAGED)
2023 NIRMATRELVIR
3 designations
VELSIPITY
2023 ETRASIMOD ARGININE
NGENLA
2023 SOMATROGON-GHLA
1 designation
CIBINQO
2022 ABROCITINIB
2 designations
NURTEC ODT
2020 RIMEGEPANT SULFATE
TALZENNA
2018 TALAZOPARIB TOSYLATE
1 designation
LORBRENA
2018 LORLATINIB
4 designations
DAURISMO
2018 GLASDEGIB MALEATE
2 designations
📋
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07492160 | 2025-07-24 | Ph 2 | recruiting | Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms |
| NCT07043322 | 874 | Ph 2 | recruiting | Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome |
| NCT07463235 SPARAGMOS | 94925726.0.1001.0068 94925726.0.1001.0068 | Ph 3 | recruiting | Safety and Potency of a High Cabergoline Dosage in Microprolactinomas |
| NCT06909123 LISTA3 | 80200 | Ph 2 | not yet recruiting | A Reduced Dose of Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss |
| NCT02288962 | 2012/677 2012-001338-32 | Ph 3 | active not recruiting | Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas |
| NCT01794793 results posted | CSOM230B2412 | Ph 4 | completed | Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies |
| NCT06123026 | STU00218555 | Ph 4 | recruiting | Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion |
| NCT02542410 results posted | P00018628 | Ph 2 | completed | Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study |
| NCT02875587 | Cabergoline/calcium gluconate | Ph 2 | completed | Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome |
| NCT01535859 | KNMRCNIG1031 NMRC/NIG/1029/2010 | Ph 3 | completed | Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers |
| NCT03271918 | 10675 | Ph 3 | completed | Cabergoline in Nonfunctioning Pituitary Adenomas |
| NCT02271360 | khalid-ahmed 7 | Ph 2, Ph 3 | completed | Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome |
| NCT01620138 results posted | CSOM230BBR01T | Ph 2, Ph 3 | completed | Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant Prolactinomas |
| NCT02134249 infertility | khalid-ahmed | Ph 2, Ph 3 | completed | Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome |
| NCT01009567 | Royan-Emb-004 | Ph 1, Ph 2 | completed | Compare the Efficacy of Human Albumin With Cabergoline to Prevent Ovarian Hyper Stimulation in Assisted Reproductive Technology (ART) Program |
| NCT01651364 | H-27036 DPMC, 2630090202 | Ph 1 | completed | A Pilot Study of Cabergoline for the Treatment of Cocaine Dependence |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DOSTINEX FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment