ANAGRELIDE HYDROCHLORIDE
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.
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.
Details
- Status
- Prescription
- First Approved
- 2005-04-18
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ANAGRELIDE HYDROCHLORIDE Approval History
What ANAGRELIDE HYDROCHLORIDE Treats
4 indicationsANAGRELIDE 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
ANAGRELIDE HYDROCHLORIDE 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 ANAGRELIDE HYDROCHLORIDE's indications
See all emerging drugs →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.
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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.
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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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.