TheraRadar
Data updated: May 26, 2026

SEIZALAM (midazolam hydrochloride)

Trial Activity: Stable 3 active trials
CNS Approved 2018-09-14
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

University of Texas Southwestern Medical Center conducting 2 trials (17%)
22 indications explored (Broad Platform)
→ healthy (2 trials)
→ substance use disorders (1 trials)
→ substance use (1 trials)
1
Indication
--
Phase 3 Trials
7
Years on Market

Details

Status
Discontinued
First Approved
2018-09-14
Routes
INTRAMUSCULAR
Dosage Forms
SOLUTION

Companies

MMT
Active Ingredient: MIDAZOLAM HYDROCHLORIDE

SEIZALAM Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2018 to 2023 · 1 indication expansions
Jan 2023 SUPPL
Label · Labeling
FDA Letter Label
Feb 2021 SUPPL
Label · Labeling
FDA Letter Label
Sep 2018 ORIGINAL
New Indication · Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
FDA Letter Label

What SEIZALAM Treats

1 FDA approvals

Originally approved for its first indication in 2018 .

  • Other (1)
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Clinical Trial Registry

13 trials
Trial Sponsor ID Phase Status Title
NCT07569198 KET-DBT 25-5431 Ph 2 not yet recruiting Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)
NCT06496750 KMD STU-2023-1086 Ph 2 recruiting Ketamine for Methamphetamine Use Disorder
NCT06867068 2014-3556 Ph 1 completed Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery
NCT05004896 KET-BD 21-5560 Ph 2 completed Ketamine for Treatment-Resistant Bipolar Disorder
NCT06480500 Ket-CBT 21-6000 Ph 2 recruiting i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial
NCT04592809 TASK STU-2020-0973 R01MH125181 Ph 3 completed Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents
NCT03556592 LP0162-1342 2018-000534-35 Ph 1 completed Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4
NCT06090422 KeDA 2022/484848(REK) 2023-506052-24, U1111-1293-2654 Ph 1, Ph 2 not yet recruiting Ketamine for Combined Depression and Alcohol Use Disorder
NCT04679623 RLM-559-01 Ph 1 completed Study of Midazolam in Healthy Adults
NCT03330990 RXDX-101-14 GO40785 Ph 1 completed Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients
NCT03457597 CORT125134-126 Ph 1 completed Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s
NCT02473627 DS1971-A-E105 Ph 1 completed A PHASE 1, OPEN-LABEL, CROSS-OVER, FIXED SEQUENCE STUDY TO EVALUATE THE EFFECT OF MULTIPLE DOSES OF DS-1971A ON THE SINGLE DOSE PHARMACOKINETICS OF PROBE SUBSTRATES FOR CYP2B6, CYP2C8, CYP2C9, CYP2C19 AND CYP3A4 ENZYMES IN HEALTHY MALE AND FEMALE SUBJECTS
NCT01218620 NCI-2012-02916 NCI-2012-02916, CDR0000685426 Ph 1 completed Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced Solid Tumors
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

SEIZALAM FDA Label Details

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Data Sources

FDA Approval: NDA209566 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment