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Lorazepam

Phase 4

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Lorazepam development status

Highest phase Phase 4 run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (NCT00624780)
Phase scored for VTRSPhase 1
Registered trials 17 across 8 sponsors since Sep 2005

Lorazepam target and mechanism

Molecular targetGABRA1, GABRB2, GABRG2, GABRB3, GABRA4, GABRG3
Target classPositive Allosteric Modulator
ModalitySmall molecule
ChEMBLCHEMBL580

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Lorazepam clinical trials

Lorazepam · 1 trial · 1 indication

Phase 1 1
NCT00649818Fasting Study of Lorazepam Tablets 2 mg and Ativan Tablets 2 mgHealthy
COMPLETED28 Analytics
PHASE1COMPLETED
Fasting Study of Lorazepam Tablets 2 mg and Ativan Tablets 2 mg
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Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALLorazepam Tablets 2 mg
2ACTIVE_COMPARATORAtivan Tablets 2 mg

Interventions

NameTypeDescription
Lorazepam Tablets 2 mgDRUG2mg, single dose fasting
Ativan Tablets 2 mgDRUG2mg, single dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administratio...

Countries:United States
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Frequently asked questions about Lorazepam

What is Lorazepam?

Lorazepam is a small molecule drug developed by Viatris Inc. (ticker VTRS) and is also known as Lorazepam Tablets 2 mg. It is a Phase 1 investigational product studied in healthy adult volunteers. Its therapeutic area is classified as Other, and the specific indications being pursued have not been disclosed.

What does Lorazepam target?

Lorazepam targets GABA-A receptor subunits, specifically GABRA1, GABRB2, GABRG2, GABRB3, GABRA4, and GABRG3. It acts as a positive allosteric modulator at these receptor sites. This target class places it among compounds that enhance GABA-A receptor signaling.

Who makes Lorazepam?

Lorazepam is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the company associated with the Lorazepam Tablets 2 mg program. The drug is a small molecule and is also known by the name Lorazepam Tablets 2 mg.

What phase is Lorazepam in?

Lorazepam is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The program has one completed Phase 1 trial, with no active trials currently listed. The single completed study enrolled 28 participants.

What clinical trials is Lorazepam in?

Lorazepam has been studied in one completed Phase 1 trial, NCT00649818, titled Fasting Study of Lorazepam Tablets 2 mg and Ativan Tablets 2 mg. The trial enrolled 28 healthy adult volunteers in the United States, used an active-controlled, randomized design, and included both male and female participants aged 18 years and older.