Hyperprolactinemia
📧 Sign up to get email alerts when something new happens for Hyperprolactinemia.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2026-03-18FDA Approved: CABERGOLINE — Supplemental Application (SOLA Pharmaceuticals, LLC)
FDA approves a supplemental application for Cabergoline from SOLA Pharmaceuticals, LLC, enabling continued use under the approved indication…
-
CLINICAL_TRIALS research · 2026-03-13Clinical Trial Update: Safety and Potency of a High Cabergoline Dosage in Microprolactinomas [Phase 3]
A Phase 3 clinical trial is evaluating the safety and efficacy of a high-dose cabergoline regimen in people with microprolactinomas. The stu…
-
FDA approval · 2025-12-11FDA Approved: CABERGOLINE — Supplemental Application (Ingenus Pharmaceuticals, LLC)
FDA approves a supplemental application for cabergoline from Ingenus Pharmaceuticals, LLC.
-
CLINICAL_TRIALS trial_result · 2025-11-17Clinical Trial Update: A Study on Bioequivalence of Cabergoline Tablets in Human Body [Phase 1]
A Phase 1 bioequivalence study of cabergoline tablets for hyperprolactinemia is being conducted, sponsored by Changchun GeneScience Pharmace…
-
CLINICAL_TRIALS research · 2025-10-02Clinical Trial Update: A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets [Phase 3]
A Phase 3 clinical trial comparing cabergoline tablets with bromocriptine mesylate tablets for hyperprolactinemia is currently recruiting.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2025-04-21FDA Approved: CABERGOLINE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for cabergoline submitted by Mylan Pharmaceuticals Inc., confirming additional approval activity…
-
CLINICAL_TRIALS research · 2025-03-11Clinical Trial Update: Impact of Helicobacter Pylori Infection on Prolactin Levels in Reproductive-Age Women to Determine Whether H. Pylori Infection is Associated with Elevated Prolactin Levels and Assess the Clinical Implications
This clinical trial update from Assiut University is examining whether Helicobacter pylori infection influences prolactin levels in reproduc…
-
FDA approval · 2024-09-09FDA Approved: CABERGOLINE — Original Application (Somerset Therapeutics, LLC)
FDA approved Somerset Therapeutics' original application for cabergoline. Cabergoline is a dopamine agonist used to treat hyperprolactinemia…
-
CLINICAL_TRIALS trial_result · 2024-08-20Clinical Trial Update: Administration of Kisspeptin in Patients With Hyperprolactinemia [Phase 2]
Phase 2 trial evaluating Kisspeptin in patients with hyperprolactinemia; the study status is completed and results have been posted.
-
CLINICAL_TRIALS research · 2024-08-12Clinical Trial Update: PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics
Clinical trial PROSA is studying prolactin, sex hormones, growth and metabolic biomarkers in children and adolescents treated with antipsych…
-
CLINICAL_TRIALS trial_result · 2024-07-31Clinical Trial Update: Kisspeptin Administration in the Adult [Phase 1]
Phase 1 clinical trial evaluating Kisspeptin administration in adults with hypogonadotropic hypogonadism and related GnRH deficiencies, incl…
-
FDA approval · 2024-06-25FDA Approved: CABERGOLINE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved the original ANDA for cabergoline from Amneal Pharmaceuticals NY LLC, bringing a generic version to market.
-
FDA approval · 2023-06-28FDA Approved: CABERGOLINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for cabergoline.
-
FDA approval · 2022-11-08FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for bromocriptine mesylate from Sandoz Inc, approving a modification to an existing generic product'…
-
FDA approval · 2022-04-27FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for bromocriptine mesylate submitted by Zydus Pharmaceuticals USA Inc.
-
CLINICAL_TRIALS trial_result · 2021-07-30Clinical Trial Update: Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole [Phase 1, Phase 2]
A Phase 1/2 clinical trial evaluated ropinirole, a non-ergoline dopamine agonist, for hyperprolactinemia and prolactinoma. The study is comp…
-
FDA label_change · 2021-01-19FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for bromocriptine mesylate from Zydus Pharmaceuticals USA Inc., resulting in labeling changes fo…
-
FDA approval · 2020-08-21FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for Bromocriptine Mesylate submitted by Padagis US LLC.
-
FDA approval · 2020-04-03FDA Approved: CYCLOSET — Supplemental Application (Avvisto Therapeutics LLC)
FDA approved a supplemental application for CYCLOSET (bromocriptine mesylate) submitted by Avvisto Therapeutics LLC.
-
FDA approval · 2019-12-13FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a Supplemental Application for Bromocriptine Mesylate by ANI Pharmaceuticals, Inc. The provided excerpt does not specify a new …
-
FDA approval · 2019-12-13FDA Approved: CABERGOLINE — Supplemental Application (SOLA Pharmaceuticals, LLC)
The FDA approved a supplemental application for cabergoline submitted by SOLA Pharmaceuticals, LLC, indicating approval of a supplemental/ g…
-
CLINICAL_TRIALS other · 2019-01-31Clinical Trial Update: Pituitary Function and Spontaneous Intracranial Hypotension
A clinical trial examining pituitary function in patients with hyperprolactinemia and spontaneous intracranial hypotension is currently susp…
-
CLINICAL_TRIALS trial_result · 2019-01-10Clinical Trial Update: Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility [Phase 2]
Phase 2 clinical trial evaluating effectiveness and safety of Bushen Culuan Decoction for anovulatory infertility; status is not specified.
-
FDA approval · 2018-08-01FDA Approved: CABERGOLINE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved Cabergoline (original application) from Ingenus Pharmaceuticals, LLC, expanding access to this dopamine agonist under an ANDA. …
-
CLINICAL_TRIALS trial_result · 2018-06-26Clinical Trial Update: Hyperprolactinaemia Management in Reproductive Services at University Hospital of Coventry and Warwickshire
Completed clinical trial update from University Hospitals Coventry and Warwickshire examining hyperprolactinaemia management in reproductive…