Bromocriptine Mesylate

For type 2 diabetes mellitus. Sold as Parlodel, Cycloset. Every FDA application for this active ingredient: 2 branded and 6 generic.

As of Nov 15, 2026, FDA lists 8 applications for Bromocriptine Mesylate (sold as Parlodel, Cycloset), first approved Jun 28, 1978, with 1 new use approved and 0 published complete response letters.

First approved: Jun 28, 1978
Applications: 8
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $7.3M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Bromocriptine Mesylate	Part D	$6.1M	-7%	6,429
Cycloset	Part D	$1.2M	-50%	383

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

BROMOCRIPTINE 2.5 MG TABLET: $1.63 per unitGeneric · -9% in a year
BROMOCRIPTINE 5 MG CAPSULE: $4.12 per unitGeneric · +9% in a year
CYCLOSET 0.8 MG TABLET: $5.25 per unitBrand · 0% in a year

Clinical Trials

5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate TabletsHyperprolactinemia · Changchun GeneScience Pharmaceutical Co., Ltd.	Phase 3	Recruiting	Aug 15, 2025
Surgical and Pharmacological Efficacy of Knosp Grade 0-2 ProlactinomaPituitary Tumor · Second Affiliated Hospital, Zhejiang University, School of Medicine	Not applicable	Not yet recruiting	Aug 15, 2024
Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive AgeDilated Cardiomyopathy · Jimma University	Phase 3	Recruiting	Feb 9, 2024
Impact of Bromocriptine on Clinical Outcomes for Peripartum CardiomyopathyPeripartum Cardiomyopathy, Postpartum · Dennis M. McNamara, MD, MS	Phase 4	Recruiting	Jan 6, 2022
Bromocriptine for Patients With Schizophrenia and PrediabetesSchizophrenia, PreDiabetes · VA Pittsburgh Healthcare System	Phase 4	Not yet recruiting	Jul 2, 2018

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jun 28, 1978	ParlodelNDA 17962 · New molecular entity	Esjay Pharma	68	Marketed
Jan 13, 1998	Bromocriptine MesylateANDA 74631	Sandoz	8	Marketed
Dec 10, 1998	Bromocriptine MesylateANDA 75100	Lek Pharm	0	Discontinued
Sep 24, 2004	Bromocriptine MesylateANDA 76962	Aurobindo Pharma USA	3	Discontinued
Apr 4, 2005	Bromocriptine MesylateANDA 77226	Mylan	3	Marketed
Jul 30, 2008	Bromocriptine MesylateANDA 78899	Zydus Pharms USA Inc	3	Marketed
Oct 1, 2008	Bromocriptine MesylateANDA 77646	Padagis US	3	Marketed
May 5, 2009	CyclosetNDA 20866 · New dosage form	Veroscience	9	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA