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Data updated: May 26, 2026

AGRYLIN (anagrelide hydrochloride)

Cardiovascular Approved 1997-03-14

Agrylin helps patients with thrombocythemia resulting from myeloproliferative neoplasms by lowering abnormally high platelet counts. It is used to decrease the risk of blood clots and manage symptoms related to bleeding or clotting complications. By controlling platelet levels, the medication helps improve the overall clinical condition of these patients.

Source: FDA Label • Takeda

How AGRYLIN Works

While the exact process is not fully known, this drug works by suppressing specific transcription factors, such as GATA-1 and FOG-1, that are necessary for the development of platelet-forming cells. This suppression ultimately leads to a reduction in the body's platelet production.

3
Indications
--
Phase 3 Trials
2
Priority Reviews
29
Years on Market

Details

Status
Prescription
First Approved
1997-03-14
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Active Ingredient: ANAGRELIDE HYDROCHLORIDE

AGRYLIN Approval History

1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
48 FDA actions from 1997 to 2021 · 2 indication expansions
Oct 2021 SUPPL
Label · Labeling
Feb 2020 SUPPL
Label · Labeling
Dec 2018 SUPPL
Label · Labeling

What AGRYLIN Treats

4 indications

AGRYLIN is approved for 4 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Thrombocythemia
  • Myeloproliferative Neoplasms
  • Thrombosis
  • Thrombo-Hemorrhagic Events
Source: FDA Label

AGRYLIN Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in AGRYLIN's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AGRYLIN treats. First-in-class if their pivotal trials read out positive.

Drugs Similar to AGRYLIN

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ANAGRELIDE HYDROCHLORIDE
ANAGRELIDE HYDROCHLORIDE
1 shared
NOVITIUM PHARMA
Shared indications:
Thrombo-hemorrhagic events
ARGATROBAN
ARGATROBAN
1 shared
Baxter
Shared indications:
Thrombosis
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT01214915 results posted SPD422-308 Ph 3 completed Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia
🔬

Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

AGRYLIN FDA Label Details

Indications & Usage

FDA Label (PDF)

AGRYLIN is indicated for the treatment of Thrombocythemia; Myeloproliferative Neoplasms; Thrombosis; Thrombo-Hemorrhagic Events.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.