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Sonata

(Zaleplon)

ApprovedSmall molecule

Sonata is one of 73 small molecule programs targeting Fed. It is currently in Approved.

3

Indications

8

Total Trials

0

Active Trials

72

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

FedCompleted

Fasting ConditionsCompleted

MemoryCompleted

FedPreclinical

Completed

Fasting ConditionsPreclinical

Completed

MemoryApproved

Completed

Competition

Competitive Landscape

48 competitors in Memory

#DrugCompanyPhaseTrials

Aricept

Ritalin

Myrbetriq

Inderal

WWyeth-Lederle Vaccines

Ambien

PPurdue Pharma LP

Intuniv

PPromius Pharma, LLC

Rilutek

AAzurity Pharmaceuticals

Mifeprex

Nuvigil

NNuvo Research GmbH

Bendopa

MMerz North America, Inc.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Fasting Conditions3 trials

Zaleplon 10mg Capsules Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00829998·40 enrolled

Zaleplon 10 mg Capsules Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00829868·42 enrolled

Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00694187·39 enrolled

Depression1 trial

Zaleplon in HIV Patients With Depression

Completed·UUniversity of Pennsylvania·Phase 2·NCT03489304·20 enrolled

Fed1 trial

Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT00694317·40 enrolled

Sleep1 trial

Cerebral MRI During Sleep

Completed·UUniversity of California, San Diego··NCT03304652·11 enrolled

Memory1 trial

Hypnotic Medications and Memory: Effect of Drug Exposure During the Night

Completed·SSt. Luke's Hospital, Chesterfield, Missouri·Phase 4·NCT01159652·26 enrolled

1 more indication

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 13, 1999

SONATA

NDA NDA020859

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Zaleplon. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Zaleplon compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Zaleplon. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020859). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Pfizer

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