AGRYLIN (anagrelide hydrochloride)
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.
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.
Details
- Status
- Prescription
- First Approved
- 1997-03-14
- Routes
- ORAL
- Dosage Forms
- CAPSULE
AGRYLIN Approval History
What AGRYLIN Treats
4 indicationsAGRYLIN 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
AGRYLIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AGRYLIN treats. First-in-class if their pivotal trials read out positive.
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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
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.