Anagrelide HCl Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 297

Clinical Trials

Numerous clinical trials spanning Phase 1 to Phase 4 evaluate anagrelide for myeloproliferative neoplasms—specifically essential thrombocythemia and elevated platelet counts—alongside pharmacokinetic and bioequivalence assessments in healthy volunteers. Diverse commercial sponsors, including Shire/Takeda, PharmaEssentia, Galena Biopharma, and Merck Sharp & Dohme, have spearheaded these investigations. Although many protocols are completed, several advanced Phase 3 and Phase 4 studies remain active or active-not-recruiting, demonstrating anagrelide's ongoing clinical evaluation in hematological disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06079879	ACTIVE_NOT_RECRUITING	Essential Thrombocythemia	Merck Sharp & Dohme LLC	2023-12-31	PHASE3
NCT04285086	ACTIVE_NOT_RECRUITING	Essential Thrombocythemia	PharmaEssentia	2020-08-25	PHASE3
NCT02962388	TERMINATED	Essential Thrombocythemia	French Innovative Leukemia Organisation	2017-01-03	PHASE2; PHASE3
NCT03232177	COMPLETED	Essential Thrombocythemia	Yuhan Corporation	2017-06-05	PHASE4
NCT03123588	TERMINATED	MPN (Myeloproliferative Neoplasms)	Incyte Corporation	2017-11-14	PHASE2
NCT03866434	COMPLETED	Healthy Volunteers	Shire	2019-02-26	PHASE1
NCT03866434	Completed	Healthy Volunteers	Shire\|Takeda	2019-02-26	Phase 1
NCT02125318	COMPLETED	Thrombocytosis; Myeloproliferative Neoplasms	Galena Biopharma, Inc.	2014-05	PHASE2
NCT00202644	COMPLETED	Thrombocythemia, Hemorrhagic	Shire	2006-01-13	PHASE4
NCT01467661	COMPLETED	Essential Thrombocythemia (ET)	Shire	2010-10-27	PHASE3
NCT02076815	COMPLETED	Essential Thrombocythemia	AOP Orphan Pharmaceuticals AG	2014-02	PHASE3
NCT01230775	COMPLETED	Essential Thrombocythaemia	AOP Orphan Pharmaceuticals AG	2010-12	PHASE3
NCT02125318	Completed	Thrombocytosis\|Myeloproliferative Neoplasms	Galena Biopharma Inc.	2014-05	Phase 2
NCT01214915	COMPLETED	Essential Thrombocythemia (ET)	Shire	2010-10-27	PHASE3
NCT01552928	COMPLETED	Healthy	Shire	2012-03-29	PHASE1
NCT01192347	Completed	Essential Thrombocythemia	Shire\|Takeda	2010-09-13	--
NCT00413634	COMPLETED	Essential Thrombocythaemia	Shire	2006-11-13	PHASE2
NCT00648024	COMPLETED	Healthy	Mylan Pharmaceuticals Inc	2003-01	PHASE1
NCT00648765	COMPLETED	Healthy	Mylan Pharmaceuticals Inc	2003-01	PHASE1
NCT01065038	COMPLETED	Essential Thrombocythaemia	AOP Orphan Pharmaceuticals AG	2002-09	PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-13)

Check the Anagrelide HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Anagrelide functions by selectively inhibiting cyclic AMP phosphodiesterase III, which elevates intracellular cyclic AMP levels and subsequently suppresses megakaryocyte maturation and platelet formation. This targeted reduction in circulating blood platelets provides significant therapeutic efficacy in controlling thrombocytosis associated with essential thrombocythemia and related myeloproliferative neoplasms.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).