Drugs / Anagrelide
Anagrelide
also known as
Anagrelide hydrochloride · Agrelin · Agrylin · Anagre Cap. · Anagrelida · Anagrelide hcl · Anagrelide hydrochloride hydrate · Anagrelide hydrochloride monohydrate · +11 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | AGRYLIN | — | 1998-12-16 – 2004-12-10 | fda.gov ↗ |
| Approved | EU (EMA) | Xagrid | — | 2004-11-15 | europa.eu ↗ |
| Approved | US (FDA) | AGRYLIN | — | 1997-03-14 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT01552928 | Mar → Jul 2012 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00648024 | Jan 2003 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00648765 | Jan 2003 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02125318 | May 2014 → May 2016 | myeloproliferative neoplasm, thrombocytosis disease | Galena Biopharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00413634 | Nov 2006 → Jan 2008 | essential thrombocythemia | Shire | Completed | No outcome recorded |
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT02076815 | Feb 2014 → Feb 2015 | essential thrombocythemia | AOP Orphan Pharmaceuticals AG | Completed | No outcome recorded |
| Phase 3 | NCT01230775 | Dec 2010 → Jan 2015 | essential thrombocythemia | AOP Orphan Pharmaceuticals AG | Completed | No outcome recorded |
| Phase 3 | NCT01467661 | Oct 2010 → May 2015 | essential thrombocythemia | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01214915 | Oct 2010 → Oct 2012 | essential thrombocythemia | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01065038 | Sep 2002 → ? | essential thrombocythemia | AOP Orphan Pharmaceuticals AG | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT03232177 | Jun 2017 → Dec 2020 | essential thrombocythemia | Yuhan Corporation | Completed | No outcome recorded |
| Phase 4 | NCT00202644 | Jan 2006 → Dec 2015 | blood platelet disease | Shire | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 2 | NCT03123588 Comparator | Nov 2017 → Aug 2020 | myeloproliferative neoplasm | Incyte Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT02962388 Comparator | Jan 2017 → Jun 2021 | essential thrombocythemia | French Innovative Leukemia Organisation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT06079879 Comparator | Dec 2023 → Jul 2027 expected | essential thrombocythemia | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04285086 Comparator | Aug 2020 → Nov 2024 overdue | essential thrombocythemia | PharmaEssentia | Active not recruiting | Met primary |
| Phase 3 | NCT02038036 Background | Mar 2014 → Sep 2015 | acquired polycythemia vera | Novartis Pharmaceuticals | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-11-25 | PharmaEssentia | Results PharmaEssentia Announces Publication of Phase 3 SURPASS-ET Results in The Lancet Haematology pharmaessentia.com ↗
Ropeginterferon alfa-2b Demonstrated Superior Efficacy and Favorable Safety Compared with Anagrelide in Hydroxyurea-Resistant or -Intolerant Essential Thrombocythemia with Leukocytosis |
| 2005-04-18 | Impax Laboratories, LLC | Regulatory IMPAX Receives Final FDA Approval for Generic Version Of Agrylin; Third Approval in 2005 amneal.com ↗
IMPAX Laboratories, Inc. (NASDAQ:IPXLE) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application for a generic version of Agrylin(R) (Anagrelide Hydrocloride) HCI 0.5 and 1.0 mg capsules. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-11-25 | PharmaEssentia | PharmaEssentia Announces Publication of Phase 3 SURPASS-ET Results in The Lancet Haematology pharmaessentia.com ↗ |
| 2005-04-18 | Impax Laboratories, LLC | IMPAX Receives Final FDA Approval for Generic Version Of Agrylin; Third Approval in 2005 amneal.com ↗ |
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Anagrelide | “A Multicenter, Open-label, Clinical Study for Efficacy and Safety Evaluation of Anagrelide in Patients with Treatment-naïve, High-risk Essential Thrombocythemia as a Primary Treatment” NCT03232177 ↗16“Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation.” NCT02038036 ↗ |
| Known as | Agrelin | ChEMBL registry synonym — accepted as the source's own label CHEMBL760 ↗ |
| Known as | Agrylin | “Agrylin® Capsules 1 mg” NCT00648765 ↗ |
| Known as | Anagre Cap. | “Drug: Anagre Cap.” NCT03232177 ↗ |
| Known as | Anagrelida | ChEMBL registry synonym — accepted as the source's own label CHEMBL760 ↗ |
| Known as | Anagrelide hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL760 ↗ |
| Known as | Anagrelide hydrochloride | “Anagrelide hydrochloride selectively reduces platelet numbers by inhibiting megakaryocyte development and maturation in humans” NCT02076815 ↗4“Anagrelide Hydrochloride Capsules 1 mg” NCT00648024 ↗ “Anagrelide Hydrochloride Capsules 1 mg” NCT00648765 ↗ “SPD422 (anagrelide hydrochloride)” NCT01467661 ↗ “Drug: Anagrelide Hydrochloride” NCT01214915 ↗ |
| Known as | Anagrelide hydrochloride hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL760 ↗ |
| Known as | Anagrelide hydrochloride monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL760 ↗ |
| Known as | Anagrelide mylan | ChEMBL registry synonym — accepted as the source's own label CHEMBL760 ↗ |
| Known as | Anagrelide Retard | “Anagrelide Retard is a new, prolonged release (PR) tablet formulation of anagrelide developed by AOP Orphan Pharmaceuticals AG.” NCT02076815 ↗ |
| Known as | Anagrelide viatris (previously anagrelide mylan) | ChEMBL registry synonym — accepted as the source's own label CHEMBL760 ↗ |
| Known as | BL-4162A | ChEMBL registry synonym — accepted as the source's own label CHEMBL760 ↗ |
| Known as | BMY-26538-01 | ChEMBL registry synonym — accepted as the source's own label CHEMBL760 ↗ |
| Known as | NSC-724577 | ChEMBL registry synonym — accepted as the source's own label CHEMBL760 ↗ |
| Known as | NSC-759170 | ChEMBL registry synonym — accepted as the source's own label CHEMBL760 ↗ |
| Known as | SPD422 | “SPD422 (anagrelide hydrochloride)” NCT01467661 ↗ |
| Known as | Thromboreductin | “Study AOP 03-007 was designed as a pivotal study to test, if Anagrelide (Thromboreductin®)was not inferior to HU with respect to efficacy in patients with ET.” NCT01065038 ↗ |
| Known as | Xagrid | ChEMBL registry synonym — accepted as the source's own label CHEMBL760 ↗ |
| Known as | Xagrid(r) | “The aim of this study is to gain additional information on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as hydroxycarbamide).” NCT00202644 ↗ |
| Modality | Small molecule | — CHEMBL760 ↗ |
| Route | Oral | “following a single, oral 1 mg (1 x 1 mg) dose administration under fasting conditions” NCT00648024 ↗ |