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Anagrelide

Phase 4FDA approved

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Anagrelide development status

FDA approval on record Dec 16, 1998 as Agrylin
Approval holderTakeda Pharms Usa
ApplicationNDA020333
Highest phase Phase 4 run by Shire (NCT00202644)
Phase scored for VTRSPhase 1
Registered trials 3 across 3 sponsors since Sep 2005

Label indication AGRYLIN is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. FDA label

Anagrelide target and mechanism

Molecular targetPDE3A, PDE3B
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL760

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment69

FDA Designations

No designations recorded

Anagrelide clinical trials

Anagrelide · 2 trials · 1 indication

Phase 1 2
NCT00648024Fasting Study of Anagrelide Hydrochloride Capsules 1 mg to Agrylin® Capsules 1 mgHealthy
COMPLETED47 Analytics
NCT00648765Fed Study of Anagrelide Hydrochloride Capsules 1 mg to Agrylin® Capsules 1 mgHealthy
COMPLETED22 Analytics
PHASE1COMPLETED
Fasting Study of Anagrelide Hydrochloride Capsules 1 mg to Agrylin® Capsules 1 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fed Study of Anagrelide Hydrochloride Capsules 1 mg to Agrylin® Capsules 1 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAnagrelide Hydrochloride Capsules 1 mg
2ACTIVE_COMPARATORAgrylin® Capsules 1 mg

Interventions

NameTypeDescription
Anagrelide Hydrochloride Capsules 1 mgDRUG1mg, single dose fasting
Agrylin® Capsules 1 mgDRUG1mg, single dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Frequently asked questions about Anagrelide

What is anagrelide?

Anagrelide is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is also known as anagrelide hydrochloride capsules 1 mg. The program is currently in Phase 1 clinical development, and the specific indication being studied is undisclosed.

What does anagrelide target?

Anagrelide targets PDE3A and PDE3B. It is classified as an inhibitor of these phosphodiesterase enzymes. This target profile places anagrelide in the small molecule modality, distinguishing it from biologic therapies that act through antibodies or recombinant proteins.

Who makes anagrelide?

Anagrelide is developed by Viatris Inc., which trades under the ticker VTRS. The company is the sponsor of the clinical program evaluating anagrelide hydrochloride capsules 1 mg. No other developer or partnership is associated with this asset in the current development record.

What phase is anagrelide in?

Anagrelide is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for the undisclosed indication being studied. The program has completed two Phase 1 trials, with no active trials currently listed.

What clinical trials is anagrelide in?

Two completed Phase 1 trials have evaluated anagrelide: NCT00648765, a fed-state study comparing anagrelide hydrochloride capsules 1 mg to Agrylin capsules 1 mg in 22 healthy volunteers, and NCT00648024, a fasting-state comparison in 47 healthy volunteers. Both were conducted in the United States.