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Anagrelide · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Anagrelide Hydrochloride Capsules 1 mg |
| 2 | ACTIVE_COMPARATOR | Agrylin® Capsules 1 mg |
| Name | Type | Description |
|---|---|---|
| Anagrelide Hydrochloride Capsules 1 mg | DRUG | 1mg, single dose fasting |
| Agrylin® Capsules 1 mg | DRUG | 1mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta-human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ev...
Anagrelide is a small molecule drug being developed by Viatris Inc. (VTRS) as a generic version of Agrylin capsules. It is currently in Phase 1 clinical trials, studied in healthy volunteers to assess bioequivalence. The drug is not yet approved and remains investigational.
Anagrelide is being developed by Viatris Inc., a pharmaceutical company traded on the NASDAQ under the ticker VTRS. The company is conducting Phase 1 clinical trials to compare its anagrelide hydrochloride capsules to the reference product Agrylin.
Anagrelide is in Phase 1 clinical development. Two Phase 1 studies have been completed, both enrolling healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
Anagrelide has two completed Phase 1 trials: NCT00648024, a fasting study comparing anagrelide hydrochloride capsules 1 mg to Agrylin capsules 1 mg, and NCT00648765, a fed study with the same comparison. Both enrolled healthy adults in the United States.
Anagrelide is the active ingredient in Agrylin. Viatris is developing anagrelide hydrochloride capsules as a generic version of Agrylin capsules 1 mg, and its Phase 1 trials are designed to demonstrate bioequivalence between the two products.