Overview
Anagrelide is a platelet-reducing agent used to lower dangerously elevated platelet levels (i.e. to treat thrombocythemia) in patients with myeloproliferative neoplasms. It is an oral imidazoquinazoline that was first approved for use in the US in 1997. It appears to carry a better response rate than other thrombocythemia treatments (e.g. busulfan, hydroxyurea) and may be better tolerated.
Background
Anagrelide is a platelet-reducing agent used to lower dangerously elevated platelet levels (i.e. to treat thrombocythemia) in patients with myeloproliferative neoplasms. It is an oral imidazoquinazoline that was first approved for use in the US in 1997. It appears to carry a better response rate than other thrombocythemia treatments (e.g. busulfan, hydroxyurea) and may be better tolerated.
Indication
Anagrelide is indicated for the treatment of thrombocythemia, secondary to malignant neoplasms, to reduce platelet count and the associated risk of thrombosis. It is also beneficial in the amelioration of thrombocythemia symptoms including thrombo-hemorrhagic events.
Associated Conditions
- Thrombocythemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/10/12 | Phase 3 | Recruiting | |||
2020/02/26 | Phase 3 | Active, not recruiting | PharmaEssentia | ||
2017/04/21 | Phase 2 | Terminated | |||
2016/11/11 | Phase 2 | Terminated | French Innovative Leukemia Organisation | ||
2014/04/29 | Phase 2 | Completed | |||
2014/03/04 | Phase 3 | Completed | |||
2012/03/13 | Phase 1 | Completed | |||
2011/05/12 | N/A | Completed | |||
2010/10/29 | Phase 3 | Completed | |||
2010/10/05 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Takeda Pharmaceuticals America, Inc. | 54092-063 | ORAL | 0.5 mg in 1 1 | 10/21/2021 | |
| Torrent Pharmaceuticals Limited | 13668-462 | ORAL | 1 mg in 1 1 | 10/21/2022 | |
| Physicians Total Care, Inc. | 54868-5443 | ORAL | 0.5 mg in 1 1 | 4/27/2012 | |
| Teva Pharmaceuticals USA, Inc. | 0172-5240 | ORAL | 1 mg in 1 1 | 5/4/2022 | |
| Chartwell RX, LLC | 62135-312 | ORAL | 0.5 mg in 1 1 | 3/7/2024 | |
| Physicians Total Care, Inc. | 54868-5385 | ORAL | 1 mg in 1 1 | 4/27/2012 | |
| Carilion Materials Management | 68151-2959 | ORAL | 0.5 mg in 1 1 | 1/8/2015 | |
| Teva Pharmaceuticals USA, Inc. | 0172-5241 | ORAL | 0.5 mg in 1 1 | 5/4/2022 | |
| Chartwell RX, LLC | 62135-313 | ORAL | 1 mg in 1 1 | 3/7/2024 | |
| Torrent Pharmaceuticals Limited | 13668-453 | ORAL | 0.5 mg in 1 1 | 10/21/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/15/2004 | ||
Authorised | 2/15/2018 | ||
Authorised | 2/15/2018 | ||
Authorised | 11/15/2004 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| AGRYLIN CAPSULE 0.5 mg | SIN12525P | CAPSULE | 0.61mg | 3/19/2004 | |
| ANAGRELIDE MEVON CAPSULES 0.5 MG | SIN17118P | CAPSULE | 0.5 mg | 10/17/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Anagrelide Hydrochloride Capsules | 国药准字H20243209 | 化学药品 | 胶囊剂 | 2/23/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ANAGRELIDE B&B anagrelide (as hydrochloride) 0.5 mg capsule bottle | 398658 | Medicine | A | 12/6/2023 | |
| ANAGRELIDE Lupin anagrelide (as hydrochloride monohydrate) 0.5 mg capsule bottle | 276297 | Medicine | A | 8/3/2017 | |
| ANAGRELIDE RMB anagrelide (as hydrochloride monohydrate) 0.5 mg capsule bottle | 276295 | Medicine | A | 8/3/2017 | |
| ANAGRELIDE B&B anagrelide (as hydrochloride) 0.5 mg capsule blister pack | 398651 | Medicine | A | 12/6/2023 | |
| ANAGRIDE anagrelide (as hydrochloride) 0.5 mg capsule blister pack | 398653 | Medicine | A | 12/6/2023 | |
| ANAGRELIDE MLabs anagrelide (as hysrochloride) 0.5 mg capsule bottle | 398654 | Medicine | A | 12/6/2023 | |
| ANAGRIDE anagrelide (as hydrochloride) 0.5 mg capsule bottle | 398659 | Medicine | A | 12/6/2023 | |
| ANAGRELIDE NEO anagrelide (as hydrochloride) 0.5 mg capsule bottle | 293283 | Medicine | A | 8/20/2018 | |
| ANAGRELIDE GPPL anagrelide (as hydrochloride) 0.5 mg capsule bottle | 293278 | Medicine | A | 8/20/2018 | |
| ANAGRELIDE NH anagrelide (as hydrochloride) 0.5 mg capsule bottle | 293280 | Medicine | A | 8/20/2018 |