Halcion

(Triazolam)

ApprovedSmall molecule

Pfizer

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Timeline

Expected Milestones

Q4 2027

N/ARecruiting

MPA

NCT03954483

Clinical

Trials by Indication[1]

Absorption1 trial

Triazolam Trial In Healthy Subjects To Compare Bioavailability Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption

Withdrawn· Pfizer logo

Pfizer·Phase 1·NCT01017926

Esketamine1 trial

A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01780259·58 enrolled

Treatment1 trial

Comparison of Triazolam and Midazolam for Anxiolysis During Dental Treatment in the Pediatric Patient

Completed·UUniversity of Pittsburgh·N/A·NCT03360123·4 enrolled

Oral1 trial

A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT01421043·34 enrolled

MPA1 trial

Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal

Recruiting·UUniversity of Manitoba·N/A·NCT03954483·42 enrolled

4 more indications

Age1 trial

Sensitivity of Project: EVO Monitor Cognitive Measurements to Pharmacological Agents

Completed·AAkili Interactive Labs, Inc.·N/A·NCT02822937·18 enrolled

Driving1 trial

Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT01888497·59 enrolled

Sedation1 trial

Oral Versus Intravenous Sedation for Ocular Procedures

Completed·—·Phase 4·NCT03246724·327 enrolled

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

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

Regulatory

FDA Approval Timeline[4]

Apr 26, 1985

HALCION

NDA NDA017892

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Triazolam. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Triazolam compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Triazolam. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA017892). 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