Recent Updates
Recently added Catalysts

Prazosin

Phase 1

Hypertension | Small molecule | Cardiovascular |Pfizer, Inc.|Trials Updated: Jul 12, 2024

Prazosin development status

Highest phase Phase 1
Registered trials 2 across 2 sponsors since Sep 2005

Prazosin target and mechanism

Molecular targetADRA1A, ADRA1D, ADRA1B
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL2

Also known as Prazosin HCl

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Prazosin clinical trials

Prazosin · 1 trial · 2 indications

Phase 1 1
NCT04967443Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride CapsulesHypertension
COMPLETED72 Analytics
PHASE1COMPLETED
Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride Capsules
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Maximum Observed Plasma Concentration (Cmax) of Prazosin
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period

Secondary Endpoints

Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prazosin
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Prazosin
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Plasma Decay Half-Life (t1/2) of Prazosin
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Prazosin Hydrochloride (HCL) 2 milligram (mg) capsule Barceloneta siteACTIVE_COMPARATOROne 2 mg capsule manufactured at the current site, Barceloneta
Prazosin HCL 2 mg capsule Ascoli siteEXPERIMENTALOne 2 mg capsule manufactured at the proposed site (Ascoli)
Prazosin HCL 1 mg capsule Ascoli siteEXPERIMENTALTwo 1 mg capsule manufactured at the proposed site, Ascoli
Prazosin HCL 5 mg capsule Barceloneta siteACTIVE_COMPARATOROne 5 mg capsule manufactured at the current site, Barceloneta
Prazosin HCL 1 x 5 mg capsule Ascoli siteACTIVE_COMPARATOROne 5 mg capsule manufactured at the proposed site, Ascoli

Interventions

NameTypeDescription
Prazosin HCl 2mgDRUGPrazosin HCL 1 X 2 mg capsule.
Prazosin HCl 1 mgDRUGPrazosin HCl 2 X 1 mg capsule.
Prazosin HCl 5 mgDRUGPrazosin HCL 1 X 5 mg capsule.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants must be 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Document (ICD). * Male and female participants who are overtly healthy as determined by medical evaluation including medical history, full physical examination, vital signs, 12-l...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Prazosin

What is Prazosin?

Prazosin is a small molecule drug developed by Pfizer, Inc. (ticker: PFE) for hypertension, within the cardiovascular therapeutic area. It is also known as Prazosin HCl or Prazosin HCl 2mg. Prazosin is an investigational product still in clinical development, with Phase 1 trials conducted to date.

What is Prazosin used for?

Prazosin is being studied for hypertension, a cardiovascular condition. Its clinical trial also listed heart failure among the conditions evaluated. Prazosin has not been approved for marketing based on the development information available, and it remains an investigational therapy in clinical development.

What does Prazosin target?

Prazosin targets the alpha-1 adrenergic receptors ADRA1A, ADRA1B, and ADRA1D. It acts as an antagonist at these receptors, meaning it blocks receptor signaling. This target class and receptor profile are the basis for its evaluation in hypertension and related cardiovascular conditions.

Who makes Prazosin?

Prazosin is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company responsible for the drug's clinical development program, including the Phase 1 bioequivalence study conducted for Prazosin hydrochloride capsules.

What phase is Prazosin in?

Prazosin is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for hypertension or any other indication based on the available development data.

What clinical trials is Prazosin in?

Prazosin has been evaluated in one completed Phase 1 trial, NCT04967443, titled a pivotal bioequivalence study to qualify manufacturing site transfer for Prazosin hydrochloride capsules. The trial enrolled 72 participants in the United States, was randomized and active-controlled, and included healthy volunteers aged 18 years and older.

Is Prazosin the same as Prazosin HCl?

Yes, Prazosin is also known as Prazosin HCl and Prazosin HCl 2mg. These names refer to the same drug, with HCl indicating the hydrochloride salt form used in the capsules studied in the Phase 1 bioequivalence trial.