Anagrelide Hydrochloride

Treats thrombocythemia, secondary. Sold as Agrylin. Every FDA application for this active ingredient: 1 branded and 9 generic.

As of Nov 15, 2026, FDA lists 10 applications for Anagrelide Hydrochloride (sold as Agrylin), first approved Mar 14, 1997, with 2 new uses approved and 0 published complete response letters.

First approved: Mar 14, 1997
Applications: 10
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $5.0M
First approved in the EU: Nov 15, 2004
First approved in Japan: Sep 26, 2014

Medicare Spending

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


Anagrelide HCl	Part D	$4.8M	+4%	5,947
Agrylin	Part D	$160K	+1%	25

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

ANAGRELIDE HCL 0.5 MG CAPSULE: $0.711 per unitGeneric · 0% in a year
ANAGRELIDE HCL 1 MG CAPSULE: $1.43 per unitGeneric · -3% in a year

Orphan Designations (FDA)

5 designations, 1 approved for the designated use; see all orphan designations

treatment of soft tissue sarcomasSartar Therapeutics Oy · designated Jul 22, 2025
Treatment of Gastrointestinal Stromal TumorsSartar Therapeutics Oy · designated Apr 24, 2023
Treatment of essential thrombocythemia.Takeda Development Center Americas, Inc. · designated Jan 27, 1988 · approved Mar 14, 1997
Treatment of thrombocytosis in chronic myelogenous leukemia.Roberts Pharmaceutical Corp. · designated Jul 14, 1986
Treatment of polycythemia vera.Roberts Pharmaceutical Corp. · designated Jun 11, 1985

Approvals in the EU (EMA)

First approved in the EU 92 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Anagrelide Viatris (previously Anagrelide Mylan), genericViatris Limited · Feb 15, 2018
Xagrid, new substanceTakeda Pharmaceuticals International AG Ireland · Nov 15, 2004

Approvals in Japan (PMDA)

First approved in Japan 210 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Agrylin, new ingredientA drug with a new active ingredient indicated for the treatment of essential thrombocythemia. · Shire Japan KK · Sep 26, 2014

Clinical Trials

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


A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)Essential Thrombocythemia · Merck Sharp & Dohme LLC	Phase 3	Active, not recruiting	Oct 12, 2023
A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated MyelofibrosisMyelofibrosis · Karyopharm Therapeutics Inc	Phase 2	Active, not recruiting	Sep 24, 2020
Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or IntoleranceEssential Thrombocythemia · PharmaEssentia	Phase 3	Active, not recruiting	Feb 26, 2020
The Ruxo-BEAT Trial in Patients With High-risk Polycythemia Vera or High-risk Essential ThrombocythemiaPolycythemia Vera (PV), Essential Thrombocythemia (ET) · RWTH Aachen University	Phase 2	Active, not recruiting	Oct 16, 2015

Applications

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


Mar 14, 1997	AgrylinNDA 20333 · New molecular entity	Takeda Pharms USA	23	Marketed
Apr 18, 2005	Anagrelide HydrochlorideANDA 76417	Watson Labs	1	Discontinued
Apr 18, 2005	Anagrelide HydrochlorideANDA 76468	Cipla	10	Marketed
Apr 18, 2005	Anagrelide HydrochlorideANDA 76489	Roxane	0	Discontinued
Apr 18, 2005	Anagrelide HydrochlorideANDA 76530	Barr Labs	1	Discontinued
Apr 18, 2005	Anagrelide HydrochlorideANDA 76683	Chartwell Rx	7	Discontinued
Apr 18, 2005	Anagrelide HydrochlorideANDA 76811	Novitium Pharma	3	Marketed
Apr 18, 2005	Anagrelide HydrochlorideANDA 76910	Impax Labs	3	Marketed
Jun 27, 2006	Anagrelide HydrochlorideANDA 77613	Rising	2	Discontinued
Jun 30, 2017	Anagrelide HydrochlorideANDA 209151	Torrent	3	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