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Meloxicam

Phase 4FDA approved

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

Meloxicam development status

FDA approval on record Jan 30, 2025 as Symbravo
Approval holderAxsome
ApplicationNDA215431
Highest phase Phase 4 run by Janssen Korea, Ltd., Korea (NCT00635349)
Phase scored for VTRSPhase 1
Registered trials 5 across 4 sponsors since Mar 2008

Label indication SYMBRAVO is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use SYMBRAVO should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with SYMBRAVO, the diagnosis of migraine should be reconsidered before SYMBRAVO is administered to treat any subsequent attacks. FDA label

Meloxicam target and mechanism

Molecular targetPTGS2
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL599

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment57

FDA Designations

No designations recorded

Meloxicam clinical trials

Meloxicam · 2 trials · 1 indication

Phase 1 2
NCT00649077Fasting Study of Meloxicam Tablets 15 mg and Mobic® Tablets 15 mgHealthy
COMPLETED30 Analytics
NCT00649675Food Study of Meloxicam Tablets 15 mg and Mobic® Tablets 15 mgHealthy
COMPLETED27 Analytics
PHASE1COMPLETED
Fasting Study of Meloxicam Tablets 15 mg and Mobic® Tablets 15 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Food Study of Meloxicam Tablets 15 mg and Mobic® Tablets 15 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMeloxicam Tablets 15 mg
2ACTIVE_COMPARATORMobic® Tablets 15 mg

Interventions

NameTypeDescription
Meloxicam Tablets 15 mgDRUG15mg, single dose fasting
Mobic® Tablets 15 mgDRUG15mg, 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 administrati...

Countries:United States
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Frequently asked questions about Meloxicam

What is Meloxicam?

Meloxicam is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is also known as Meloxicam Tablets 15 mg. The specific therapeutic indication for this asset is undisclosed, and it falls under the therapeutic area classified as Other. It is currently in Phase 1 clinical development.

What does Meloxicam target?

Meloxicam targets PTGS2, also known as cyclooxygenase-2. It acts as an inhibitor of this enzyme. PTGS2 is involved in the inflammatory response, and inhibiting it is the mechanism by which this small molecule exerts its pharmacological activity.

Who makes Meloxicam?

Meloxicam is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the clinical development of Meloxicam Tablets 15 mg. The drug is a small molecule currently in Phase 1 testing.

What phase is Meloxicam in?

Meloxicam is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, with no active trials currently ongoing. The completed trials enrolled a total of 57 participants.

What clinical trials is Meloxicam in?

Meloxicam has been studied in two completed Phase 1 trials. NCT00649675 was a food study of Meloxicam Tablets 15 mg versus Mobic Tablets 15 mg, enrolling 27 healthy volunteers. NCT00649077 was a fasting study of the same comparison, enrolling 30 healthy volunteers. Both trials were conducted in the United States.