Recent Updates
Recently added Catalysts

Buspirone

Phase 2FDA approved

Undisclosed | Small molecule | Other |Teva Pharmaceutical Industries Limited|Trials Updated: Aug 19, 2024

Buspirone development status

FDA approval on record Dec 20, 2000 as Buspar
Approval holderBristol Myers Squibb
ApplicationNDA021190
Highest phase Phase 2 run by Pfizer (NCT00174226)
Phase scored for TEVAPhase 1
Registered trials 2 across 2 sponsors since Sep 2005

Buspirone target and mechanism

Molecular targetHTR1A
Target classPartial Agonist
ModalitySmall molecule
ChEMBLCHEMBL49

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment94

FDA Designations

No designations recorded

Buspirone clinical trials

Buspirone · 2 trials · 1 indication

Phase 1 2
NCT00840398Buspirone Hydrochloride 30mg Tablets, Non-FastingHealthy
COMPLETED24 Analytics
NCT00840606Buspirone Hydrochloride 30mg Tablets, FastingHealthy
COMPLETED70 Analytics
PHASE1COMPLETED
Buspirone Hydrochloride 30mg Tablets, Non-Fasting
HealthyUnlock trial analytics
PHASE1COMPLETED
Buspirone Hydrochloride 30mg Tablets, Fasting
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax
Blood samples collected over 24 hour period
Bioequivalence based on AUC0-inf
Blood samples collected over 24 hour period
Bioequivalence based on AUC0-t
Blood samples collected over 24 hour period
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
BUSPAR® 30 mg TabletDRUG1 x 30 mg, single-dose fed
Buspirone Hydrochloride 30 mg TabletDRUG1 x 30 mg, single-dose fed
Unlock Study Design Details

Eligibility Criteria

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

Inclusion Criteria: * Screening Demographics: All volunteers selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The volunteer's body mass index (BMI) is less than or equal to 30. * Screening Procedures: Each volunteer will complete the screening pro...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Buspirone

What is Buspirone?

Buspirone is a small molecule drug developed by Teva Pharmaceutical Industries Limited under the ticker TEVA. It is also known as Buspirone Hydrochloride 30 mg Tablet. The drug is currently in Phase 1 clinical development, with two completed trials involving healthy volunteers.

What does Buspirone target?

Buspirone targets the HTR1A receptor, also known as the serotonin 1A receptor. It acts as a partial agonist at this target. This mechanism is specific to the drug's molecular action as a small molecule.

Who makes Buspirone?

Buspirone is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker symbol TEVA. Teva is the company responsible for the clinical development of this drug asset.

What phase is Buspirone in?

Buspirone is in Phase 1 clinical development. It has completed two Phase 1 trials and is not currently approved for any indication. The trials were conducted in healthy volunteers.

What clinical trials is Buspirone in?

Buspirone has been studied in two completed Phase 1 trials: NCT00840606, titled Buspirone Hydrochloride 30mg Tablets, Fasting, and NCT00840398, titled Buspirone Hydrochloride 30mg Tablets, Non-Fasting. Both enrolled healthy volunteers in the United States.