Versed

(Midazolam hydrochloride)

Phase 1Small molecule

CConrado Roberto Hoffmann Filho

Versed is one of 39 small molecule programs targeting Depression. It is currently in Phase 1.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

DepressionRecruiting

TP53 Y220C MutationRecruiting

DepressionPreclinical

Recruiting

TP53 Y220C MutationPhase 1

Recruiting

Competition

Competitive Landscape

44 competitors in Depression

#DrugCompanyPhaseTrials

Cymbalta

Jazz Pharmaceuticals

Approved

13 2

Ketalar

AAultman Health Foundation

Approved

23 3

Brintellix

Takeda

Approved

7 4

Zoloft

VViatris Specialty LLC

Approved

21 5

Vraylar

AbbVie

Approved

4 6

Prozac

VVitae Pharmaceuticals Inc., an Allergan affiliate

Approved

14 7

Wellbutrin

GGlaxo Dba Glaxosmithkline

Approved

10 8

Estrace

Novo Nordisk

Approved

1 9

Spravato

WWim Janssens

Approved

4 10

Risperdal

WWim Janssens

Approved

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Substance Use Disorders

NCT06496750

Q3 2027

PreclinicalRecruiting

Depression

NCT06090422

Q1 2028

Phase 1Recruiting

TP53 Y220C Mutation

NCT07372625

Q3 2029

Phase 2Recruiting

Borderline Personality Disorder (BPD)

NCT07569198

Clinical

Trials by Indication[1]

Suicidality1 trial

Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents

Completed·UUniversity of Texas Southwestern Medical Center·Phase 3·NCT04592809·50 enrolled

Caffeine1 trial

Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Warfarin, Omeprazole, Caffeine, and Dextromethorphan in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02256813·20 enrolled

Patients With Advanced Solid Tumors1 trial

Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01218620·17 enrolled

Intravenous1 trial

Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery

Completed·—·Phase 1·NCT06867068·73 enrolled

Treatment Resistant Depression1 trial

i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT06480500·110 enrolled

13 more indications

Treatment1 trial

Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

Unknown status·MMedical University of Vienna·Phase 2·NCT02992496·60 enrolled

Single Dose1 trial

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

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT02473627·18 enrolled

Midazolam1 trial

Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients

Completed· Roche logo

Roche·Phase 1·NCT03330990·15 enrolled

Amnesia1 trial

Effect of Affective Content on Drug Induced Amnesia of Episodic Memory

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT00142493·79 enrolled

Atopic Dermatitis1 trial

Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4

Completed· LEO Pharma logo

LEO Pharma·Phase 1·NCT03556592·40 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Intranasal Dexmedetomidine

Unknown status·UUnknown Sponsor·Phase 4·NCT02985697·100 enrolled

Laparoscopic Cholecystectomy1 trial

Laparoscopic Cholecystectomy: General Anesthesia With Opioid Versus General Opioid Free Anesthesia

Unknown status·FFederal University of São Paulo·Phase 4·NCT02953210·40 enrolled

Bipolar Disorder1 trial

Ketamine for Treatment-Resistant Bipolar Disorder

Completed·JJoshua Rosenblat·Phase 2·NCT05004896·71 enrolled

TP53 Y220C Mutation1 trial

A Phase 1, Open-label, 2-part, Drug-Drug Interaction Study to Evaluate the Effects of Multiple Oral Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation.

Recruiting·PPMV Pharmaceuticals, Inc·Phase 1·NCT07372625·14 enrolled

Substance Use Disorders1 trial

NIDA CTN-0132 Randomized, Double-Blind, Active Placebo-Controlled Trial of Ketamine for Methamphetamine Use Disorder (KMD)

Active, not recruiting·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT06496750·120 enrolled

Borderline Personality Disorder (BPD)1 trial

Combining Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder: A Phase II Randomized, Midazolam-Controlled Clinical Trial (KET-DBT)

Recruiting·JJoshua Rosenblat·Phase 2·NCT07569198·120 enrolled

Depression1 trial

Ketamine for Combined Depression and Alcohol Use Disorder: A Blinded Randomized Active Placebo-controlled Trial (the KeDA Trial)

Recruiting·UUniversity Hospital of North Norway·Preclinical·NCT06090422·34 enrolled

Unspecified1 trial

Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s

Completed·CCorcept Therapeutics·Phase 1·NCT03457597·27 enrolled

Regulatory

FDA Approval Timeline[4]

May 26, 1987

VERSED

NDA NDA018654

Oct 15, 1998

VERSED

NDA NDA020942

Sep 14, 2018

SEIZALAM

NDA NDA209566

May 17, 2019

NAYZILAM

NDA NDA211321

Mar 22, 2021

MIDAZOLAM IN 0.9% SODIUM CHLORIDE

NDA NDA211844

Jul 20, 2022

MIDAZOLAM IN 0.8% SODIUM CHLORIDE

NDA NDA215868

Aug 8, 2022

MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)

NDA NDA216359

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Midazolam hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Midazolam hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Midazolam hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA216359). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Conrado Roberto Hoffmann Filho company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: CConrado Roberto Hoffmann Filho

Versed

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q1 2028

Q3 2029

Trials by Indication[1]

Suicidality1 trial

Caffeine1 trial

Patients With Advanced Solid Tumors1 trial

Intravenous1 trial

Treatment Resistant Depression1 trial

Treatment1 trial

Single Dose1 trial

Midazolam1 trial

Amnesia1 trial

Atopic Dermatitis1 trial

Safety and Efficacy1 trial

Laparoscopic Cholecystectomy1 trial

Bipolar Disorder1 trial

TP53 Y220C Mutation1 trial

Substance Use Disorders1 trial

Borderline Personality Disorder (BPD)1 trial

Depression1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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