Drugs / Cabergoline
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | DOSTINEX | — | 2011-08-11 | fda.gov ↗ |
| Approved | US (FDA) | DOSTINEX | — | 1996-12-23 | fda.gov ↗ |
Trials 39
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials · 1 missed | ||||||
| Phase 0 | NCT01730729 | Feb 2013 → Dec 2015 | female breast carcinoma | Northwestern University | Completed | No outcome recorded |
| Phase 0 | NCT01530490 | Aug 2007 → Aug 2008 | ovarian disorder | Hospital de Cruces | Completed | Missed primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01009567 | Jun 2009 → Jun 2013 | ovarian hyperstimulation syndrome | Royan Institute | Completed | No outcome recorded |
| Phase 29 trials · 2 met primary | ||||||
| Phase 2 | NCT06909123 | Jul 2026 → Jan 2027 | lactation disease | Stanford University | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT07492160 | Mar 2026 → Feb 2028 expected | pregnancy disorder | Jefferson Drapkin | Recruiting | No outcome recorded |
| Phase 2 | NCT07072910 | Nov 2025 → Mar 2028 expected | migraine disorder | Aarhus University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06029673 | Feb 2024 → Jun 2025 | lactation disease | Stanford University | Completed | Met primary |
| Phase 2 | NCT04701333 | Apr 2021 → Jun 2022 | lactation disease | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT06560814 | Jul 2020 → Jun 2021 | endometriosis, female infertility | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 2 | NCT03928288 | Dec 2019 → Jan 2026 | endometriosis | Boston Children's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02542410 | May 2016 → Sep 2018 | endometriosis | Boston Children's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01915303 | Mar 2014 → Sep 2016 | Cushing syndrome | Novartis Pharmaceuticals | Terminated | Met primary |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03549741 | Jul 2018 → Jun 2019 | infertility disorder | Assiut University | Unknown | No outcome recorded |
| Phase 2/3 | NCT02306564 | Dec 2014 → Nov 2017 | infertility disorder | Kasr El Aini Hospital | Unknown | No outcome recorded |
| Phase 39 trials · 1 met primary | ||||||
| Phase 3 | NCT07124221 | Sep 2025 → Nov 2026 expected | hyperprolactinemia | Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT03313661 | Oct 2017 → Oct 2020 | type 2 diabetes mellitus | Tanta University | Unknown | No outcome recorded |
| Phase 3 | NCT03271918 | Feb 2015 → Feb 2017 | non-functioning pituitary adenoma | University of Sao Paulo General Hospital | Completed | Met primary |
| Phase 3 | NCT02288962 | Nov 2014 → Dec 2026 expected | adenoma, pituitary tumor | St. Olavs Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01535859 | Apr 2012 → Jun 2015 | ovarian hyperstimulation syndrome | KK Women's and Children's Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00889525 | Nov 2007 → ? | ACTH-producing pituitary gland adenoma, Cushing disease due to pituitary adenoma | Seth Gordhandas Sunderdas Medical College | Completed | No outcome recorded |
| Phase 3 | NCT00440258 | Apr 2004 → Jul 2006 | ovarian hyperstimulation syndrome | Instituto Valenciano de Infertilidad, IVI VALENCIA | Completed | No outcome recorded |
| Phase 3 | NCT00625547 | Jan 2003 → Dec 2004 | restless legs syndrome | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00627003 | Nov 2002 → May 2003 | restless legs syndrome | Pfizer | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT07034859 | May 2024 → Oct 2028 expected | pituitary gland adenoma | National Taiwan University Hospital | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06123026 | Dec 2023 → Jun 2024 overdue | lactation disease | Northwestern University | Recruiting | No outcome recorded |
| Phase 4 | NCT04096027 | Sep 2019 → Jun 2021 | female infertility | Fertility Center of Las Vegas | Completed | No outcome recorded |
| Phase 4 | NCT01957839 | Mar 2010 → Aug 2011 | drug allergy | Istanbul Bakirkoy Maternity and Children Diseases Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01278342 | Sep 2006 → Nov 2009 | acromegaly | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00376064 | Mar 2006 → Jan 2010 | acromegaly | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00174239 | Jul 2004 → Sep 2005 | Parkinson disease | Pfizer | Terminated | No outcome recorded |
| Phase not applicable9 trials · 1 missed | ||||||
| — | NCT07255911 | Feb 2025 → Jan 2026 overdue | polycystic ovary syndrome | Mst.Sumyara Khatun | Recruiting | No outcome recorded |
| — | NCT05525611 | Sep 2022 → Jun 2023 | migraine disorder | University of Aarhus | Completed | Missed primary |
| — | NCT04038749 | Jun 2019 → Jul 2022 | lactation disease | Żelazna Medical Centre, LLC | Unknown | No outcome recorded |
| — | NCT03717454 | Dec 2018 → Dec 2021 | prolactin-producing pituitary gland adenoma | Zhebao Wu | Unknown | No outcome recorded |
| — | NCT03714763 | Nov 2018 → Nov 2021 | pituitary gland adenoma | Zhebao Wu | Unknown | No outcome recorded |
| — | NCT03400865 | Oct 2018 → Dec 2020 | prolactin-producing pituitary gland adenoma | Zhebao Wu | Unknown | No outcome recorded |
| — | NCT03457389 | Feb 2018 → Dec 2024 | prolactin-producing pituitary gland adenoma | Seoul National University Hospital | Unknown | No outcome recorded |
| — | NCT01459601 | Jan → Feb 2012 | type 2 diabetes mellitus | Mashhad University of Medical Sciences | Unknown | No outcome recorded |
| — | NCT00129181 | Jan 2005 → Dec 2006 | Parkinson disease | Institute for Neurodegenerative Disorders | Completed | No outcome recorded |
| Comparator or background therapy29 trials | ||||||
| Phase 1 | NCT04262024 Comparator | Feb 2020 → Jan 2023 | — | Woman's Health University Hospital, Egypt | Completed | No outcome recorded |
| Phase 1 | NCT01651364 Comparator | Jul → Oct 2011 | cocaine abuse, cocaine dependence | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 1/2 | NCT01395602 Comparator | Apr 2002 → Sep 2003 | glucose intolerance | Columbia University | Completed | No outcome recorded |
| Phase 2 | NCT07043322 Comparator | Jun 2025 → Oct 2026 expected | female reproductive system disorder | Tanta University | Recruiting | No outcome recorded |
| Phase 2 | NCT05981742 Comparator | Sep 2022 → Mar 2023 | polycystic ovary syndrome | Al-Rasheed University College | Completed | No outcome recorded |
| Phase 2 | NCT02875587 Comparator | Oct 2016 → Aug 2018 | ovarian hyperstimulation syndrome | Aljazeera Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02644304 Comparator | May 2015 → Oct 2016 | female reproductive system disorder | Woman's Health University Hospital, Egypt | Unknown | No outcome recorded |
| Phase 2 | NCT02461875 Comparator | May 2013 → Nov 2015 | ovarian hyperstimulation syndrome | Aljazeera Hospital | Unknown | Met primary |
| Phase 2 | NCT00033111 Comparator | Jun 2001 → Apr 2004 | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2/3 | NCT02271360 Comparator | Apr 2014 → Dec 2015 | infertility disorder | Benha University | Completed | No outcome recorded |
| Phase 2/3 | NCT02134249 Comparator | Apr 2014 → Sep 2015 | infertility disorder | Benha University | Completed | No outcome recorded |
| Phase 2/3 | NCT01620138 Comparator | Mar 2010 → Jun 2012 | non-functioning pituitary adenoma, prolactin-producing pituitary gland adenoma | Federal University of Rio de Janeiro | Completed | No outcome recorded |
| Phase 3 | NCT07463235 Comparator | Mar 2026 → Aug 2027 expected | hyperprolactinemia, prolactin-producing pituitary gland adenoma | University of Sao Paulo General Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT02620605 Comparator | Dec 2017 → Dec 2018 | ovarian hyperstimulation syndrome | Mona M Shaban | Unknown | No outcome recorded |
| Phase 3 | NCT03473613 Comparator | Oct 2014 → Apr 2017 | ovarian hyperstimulation syndrome | Benha University | Completed | No outcome recorded |
| Phase 4 | NCT07603466 Comparator | May 2026 → Jun 2028 expected | ACTH-dependent Cushing syndrome | University of Basrah | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT07386080 Comparator | May 2026 → May 2028 expected | schizophrenia | Zealand University Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07045935 Comparator | Sep 2025 → Dec 2029 expected | prolactin-producing pituitary gland adenoma | University Hospital, Basel, Switzerland | Recruiting | No outcome recorded |
| Phase 4 | NCT04107480 Comparator | Jun 2019 → Mar 2024 | prolactin-producing pituitary gland adenoma | Leiden University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT03263299 Comparator | Aug 2017 → Aug 2018 | — | Cairo University | Unknown | No outcome recorded |
| Phase 4 | NCT01794793 Background | Jun 2013 → Jul 2023 | Cushing disease due to pituitary adenoma, acromegaly, dumping syndrome, ectopic ACTH secretion syndrome +3 | RECORDATI GROUP | Completed | No outcome recorded |
| Phase 4 | NCT00595140 Comparator | Jan → Mar 2008 | acromegaly | Ludwig-Maximilians - University of Munich | Completed | No outcome recorded |
| Phase 4 | NCT00153972 Comparator | Feb 2005 → Sep 2008 | Parkinson disease | Technical University Dresden | Completed | No outcome recorded |
| — | NCT07568574 Background | Mar 2026 → May 2028 expected | — | Enhanced Emirates Limited | Enrolling by invitation | No outcome recorded |
| — | NCT07168837 Comparator | Jan 2023 → May 2024 | polycystic ovary syndrome | Al-Azhar University | Completed | No outcome recorded |
| — | NCT06333691 Comparator | Oct 2022 → Feb 2024 | ovarian hyperstimulation syndrome | Minia University | Completed | No outcome recorded |
| — | NCT05024422 Comparator | Dec 2021 → Nov 2022 | lactation disease | HaEmek Medical Center, Israel | Completed | No outcome recorded |
| — | NCT01143584 Comparator | May 2010 → Dec 2011 | prolactin-producing pituitary gland adenoma | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| — | NCT01569256 Comparator | Mar 2008 → Mar 2009 | ovarian hyperstimulation syndrome, polycystic ovary syndrome | Etlik Zubeyde Hanim Womens' Health and Teaching Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2007-03-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives Approval For Generic Dostinex® Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Cabergoline Tablets, 0.5 mg. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2007-03-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives Approval For Generic Dostinex® Tablets tevapharm.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 71 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cabergoline | “Cabergoline which is a dopamine receptor agonist, with higher affinity to dopamine D2 receptors had improved uterine perfusion and achieved a better ovulatory response in PCOS patients” NCT07168837 ↗67“Subjects who show high expression of dopamine D2 receptors in PET-MR imaging will be treated with Cabergoline(CAB) tablets 2mg/week or bromocriptine(BC) tablets 7.5mg/ day.” NCT03714763 ↗ “Cabergoline tablet 0.5mg or 1.0mg taken by mouth once daily may be combined with subcutaneous formulation of pasireotide for Cushing's Disease or Acromegaly.” NCT01794793 ↗ “Current first line treatment consists of a dopamine agonists: cabergoline (currently the most used), bromocriptine or quinagolide.” NCT04107480 ↗ “The dopamine agonist(DA),such as cabergoline(CAB) and bromocriptine(BC), has been used widely in the treatment of prolactinomas” NCT03717454 ↗ “Subjects are treated with hydroxychloroquine sulfate tablets 5mg/kg Bid and cabergoline tablets 2mg/week for 3 months.” NCT03400865 ↗ “took cabergoline (Dostinex 0.5 mg, Pfizer, Montreal, Canada) orally daily for 8 days after hCG triggering” NCT06333691 ↗ |
| Known as | CAB | “The dopamine agonist cabergoline (CAB) has been used widely in the treatment of prolactinomas and other types of pituitary adenomas, but its clinical use is hampered by...” PMID 28973192 ↗ Oct 20172“Subjects who show high expression of dopamine D2 receptors in PET-MR imaging will be treated with Cabergoline(CAB) tablets 2mg/week or bromocriptine(BC) tablets 7.5mg/ day.” NCT03714763 ↗ “The dopamine agonist(DA),such as cabergoline(CAB) and bromocriptine(BC), has been used widely in the treatment of prolactinomas” NCT03717454 ↗ |
| Known as | Cabaser | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201087 ↗ |
| Known as | Cabergolina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201087 ↗ |
| Known as | Cb2 | “PURPOSE: To compare the efficacy of cabergoline (Cb2) and intravenous human albumin (HA) in the prevention of ovarian hyperstimulation syndrome.” PMID 22231013 ↗ Jan 2012 |
| Known as | Dostinex | “Cabergoline (Dostinex; Pfizer, Italy) at a daily dose of 0.5 mg is administered orally at bed time for 8 days starting on the day of HCG administration” NCT02875587 ↗2“took cabergoline (Dostinex 0.5 mg, Pfizer, Montreal, Canada) orally daily for 8 days after hCG triggering” NCT06333691 ↗ “Cabergoline (Dostinex ®) 0.5 mg/tablet.” NCT07034859 ↗ |
| Known as | FCE 21336 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201087 ↗ |
| Known as | Velactis | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201087 ↗ |
| Action | Activate | “the dopamine D2 agonist cabergoline” NCT00153972 ↗1“Dopamine D2 receptor agonist” CHEMBL1201087 ↗ |
| Modality | Small molecule | — CHEMBL1201087 ↗ |
| Route | Oral | “Cabergoline 3 mg per day orally.” NCT00153972 ↗ |
| Target | DRD2 | “Dopamine D2 receptor agonist” CHEMBL1201087 ↗ |