Trial	Phase	Status	Sponsor	Enrollment	Dates
Bromocriptine for Patients With Schizophrenia and Prediabetes NCT03575000	Phase 4	Not Yet Recruiting	VA Pittsburgh Healthcare System	15	2026-01-01 → 2026-07-31
Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes NCT02544321	Phase 2	Completed	University of Colorado, Denver	108	2015-09 → 2019-06
Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy NCT00998556	Phase 2	Completed	Hannover Medical School	64	2010-06 → 2016-08
Bromocriptine-QR Therapy on Sympathetic Tone and Vascular Biology in Type 2 Diabetes Subjects NCT02682901	Phase 4	Completed	Eastern Virginia Medical School	84	2015-10-05 → 2018-11-15
Effect of Cycloset on Glycemic Control When Added to Glucagon-like Peptide 1 (GLP-1) Analogue Therapy NCT02299050	Phase 4	Completed	The University of Texas Health Science Center at San Antonio	23	2014-06 → 2018-04-30
Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets in Children and Adolescent Type 2 Diabetes Mellitus Subjects NCT02078440	Phase 1	Completed	VeroScience	18	2014-01 → 2016-06
Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole and Bromocriptine in Parkinson's Disease NCT00240409	Phase 3	Completed	Boehringer Ingelheim	208	2003-07 → 2004-08
Vaginal Bromocriptine for Treatment of Adenomyosis NCT01821001	Phase 1	Completed	Mayo Clinic	1	2013-03 → 2018-01
Dopamine Receptor Contributions to Prediction Error and Reversal Learning in Anorexia Nervosa NCT04128683	Early Phase 1	Completed	University of California, San Diego	31	2020-10-20 → 2025-01-01
QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes NCT01474018	Phase 4	Completed	University of Texas Southwestern Medical Center	15	2011-11 → 2012-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$5.26

per ea

Lowest NADAC/Unit

$5.26

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
73515012330CYCLOSET 0.8 MG TABLET	$5.26	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$823.40

Highest Price

$823.40

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
73515-0123-30CYCLOSET 0.8MG TAB	$823.40	FSS	Avvisto Therapeutics LLC	09/14/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Cycloset (2024)

Total Spending

$2.4M

Total Claims

2,635

Beneficiaries

620

Avg Cost/Unit

$5.41

Spending Trend

$3.9M(2019)→$3.9M(2020)→$4.0M(2021)→$3.6M(2022)→$3.2M(2023)→$2.4M(2024)

YoY Change:-5.7%

5yr CAGR:+5.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs5 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

LEK PHARMACEUTICALS DDBROMOCRIPTINE MESYLATE USP

DMF 68271987

CURIA ITALY SRLBROMOCRIPTINE MESYLATE

DMF 69551987

TAPI NL BVBROMOCRIPTINE MESYLATE

DMF 147682000

GEDEON RICHTER LTDInactiveBROMOCRIPTINE MESYLATE USP

DMF 67371986

CHEMAPOL LTDInactiveBROMOCRIPTINE MESYLATE

DMF 69841987

LABOCHIMInactiveBROMOCRIPTINE MESYLATE

DMF 70881987

CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTDInactiveBROMOCRIPTINE MESYLATE

DMF 106791993

GALENA ASInactiveBROMOCRIPTINE MESYLATE

DMF 119731996

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Aug 18, 2020	SUPPL -12	View Letter (PDF)
Apr 6, 2020	SUPPL -13	View Letter (PDF)
Feb 7, 2017	SUPPL -6	View Letter (PDF)
Feb 7, 2017	SUPPL -7	View Letter (PDF)
Feb 4, 2016	SUPPL -9	View Letter (PDF)
Oct 21, 2015	SUPPL -8	View Letter (PDF)
Mar 28, 2011	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.8MG BASE

RLD

13 patents0 exclusivities▴

TABLET;ORAL | Approved: May 5, 2009

Patents (13) · 126 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8431155	Apr 30, 2032	—	—	Yes	—
8613947	Apr 30, 2032	—	—	Yes	—
8877708	Jun 7, 2030	—	—	Yes	—
9192576	Apr 30, 2032	—	—	Yes	—
9352025	Jun 7, 2030	—	—	—	—
9522117	Apr 30, 2032	—	—	Yes	—
9700555	Apr 30, 2032	—	—	Yes	—
9895422	Jun 7, 2030	—	—	—	—
9993474	Apr 30, 2032	—	—	—	—
10688094	Apr 30, 2032	—	—	—	—
10688155	Jun 7, 2030	—	—	—	—
11000522	Apr 30, 2032	—	—	—	—
11666567	Apr 30, 2032	—	—	—	—