TheraRadar
Data updated: May 26, 2026

ANAGRELIDE HYDROCHLORIDE

Cardiovascular Approved 2005-04-18

Anagrelide hydrochloride helps patients with thrombocythemia that occurs as a result of myeloproliferative neoplasms. It is used to lower high platelet counts, which helps reduce the risk of blood clots. By managing these levels, the medication also helps improve symptoms related to clotting and bleeding events.

Source: FDA Label • NOVITIUM PHARMA

How ANAGRELIDE HYDROCHLORIDE Works

Although the exact mechanism is not fully known, the drug works by suppressing the expression of specific transcription factors like GATA-1 and FOG-1. These factors are required for the development of platelets, and blocking them leads to a decrease in platelet production.

Source: FDA Label
3
Indications
--
Phase 3 Trials
21
Years on Market

Details

Status
Prescription
First Approved
2005-04-18
Routes
ORAL
Dosage Forms
CAPSULE

ANAGRELIDE HYDROCHLORIDE Approval History

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
78 FDA actions from 2005 to 2026
Feb 2026 SUPPL
Label · Labeling
Feb 2026 SUPPL
Label · Labeling
Jan 2026 SUPPL
Label · Labeling

What ANAGRELIDE HYDROCHLORIDE Treats

4 indications

ANAGRELIDE HYDROCHLORIDE is approved for 4 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Thrombocythemia secondary to myeloproliferative neoplasms
  • Elevated platelet count
  • Risk of thrombosis
  • Thrombo-hemorrhagic events
Source: FDA Label

ANAGRELIDE HYDROCHLORIDE 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 ANAGRELIDE HYDROCHLORIDE's indications

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

Drugs Similar to ANAGRELIDE HYDROCHLORIDE

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

AGRYLIN
ANAGRELIDE HYDROCHLORIDE
1 shared
Takeda
Shared indications:
Thrombo-Hemorrhagic Events
📋

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.

ANAGRELIDE HYDROCHLORIDE FDA Label Details

Indications & Usage

ANAGRELIDE HYDROCHLORIDE is indicated for the treatment of Thrombocythemia secondary to myeloproliferative neoplasms; Elevated platelet count; Risk of thrombosis; Thrombo-hemorrhagic events.

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AGRYLIN

Full clinical data, patents, trials, and competitive landscape for anagrelide hydrochloride.

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Data Sources

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