Agrylin

(Anagrelide)

Phase 3Small molecule

Takeda

Agrylin is one of 32 small molecule programs targeting Essential Thrombocythemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Essential ThrombocythemiaActive, not recruiting

Essential ThrombocythemiaPhase 3

Active, not recruiting

Competition

Competitive Landscape

44 competitors in Essential Thrombocythemia

#DrugCompanyPhaseTrials

Droxia

TTheravia

Approved

3 2

Jakafi

Incyte

Phase 3

12 3

Zolinza

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Trisenox

Bayer Aspirin

2 6

PEGASYS

Ppharmaand GmbH

Phase 3

3 7

Vonjo

OOrsoBio, Inc

Phase 3

2 8

Busulfex

Akero Therapeutics

Phase 3

1 9

BESREMI

PPharmaEssentia

Phase 3

1 10

Bomedemstat

Merck & Co.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2028

Phase 3Active, not recruiting

Essential Thrombocythemia

NCT06079879

Q3 2029

Phase 3Active, not recruiting

Essential Thrombocythemia

NCT04285086

Clinical

Trials by Indication[1]

Essential Thrombocythemia4 trials

Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)

Terminated· Incyte logo

Incyte·Phase 2·NCT03123588·12 enrolled

A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients

Completed· Takeda logo

Takeda·Phase 4·NCT00202644·150 enrolled

Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance

Active, not recruiting·PPharmaEssentia·Phase 3·NCT04285086·174 enrolled

Show 1 more trial

A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543/IMG-7289) Versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia Who Have an Inadequate Response to or Are Intolerant of Hydroxyurea

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06079879·340 enrolled

Efficacy1 trial

Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia

Completed·AAOP Orphan Pharmaceuticals AG·Phase 3·NCT01065038

Function1 trial

Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers

Completed· Takeda logo

Takeda·Phase 1·NCT01552928·60 enrolled

High Risk1 trial

The Ruxolitinib Versus Best Available Therapy Trial in Patients With High Risk ET in Second Line

Terminated·FFrench Innovative Leukemia Organisation·Phase 2/3·NCT02962388·13 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 14, 1997

AGRYLIN

NDA NDA020333

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Anagrelide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Anagrelide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Anagrelide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020333). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Takeda

Agrylin

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2028

Q3 2029

Trials by Indication[1]

Essential Thrombocythemia4 trials

Efficacy1 trial

Function1 trial

High Risk1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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