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Melatonin

Phase 2

Pain, Postoperative | Small molecule | Pain |Quest Diagnostics Inc.|Last Updated: Jan 30, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04791943Preoperative Melatonin to Decrease Analgesia Usage After Third Molar SurgeryPHASE2 COMPLETED 60Nov 16, 2021Oct 20, 2025Jan 30, 20261 United States
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Study Endpoints
Primary Endpoints
Postoperative narcotic consumption
From the time of intervention to the completion of the surveys, approximately 2-4 weeks total

Postoperative consumption of narcotic pain medication will be measured for approximately 72 hours post operatively. Three total surveys will be administered. The surveys will be sent to participants via text message or email and include a link to SurveyMonkey. These surveys will be sent in the morning approximately 1 day, 2 days, and 3 days after surgery. The surveys will query for participant identification and then ask how many tablets of ibuprofen 600mg and hydrocodone-acetaminophen have been taken since the time of surgery or the time of previous survey depending on if the survey is received on Day 1, versus Day 2, and Day 3. The number of narcotic pain medication pills consumed postoperatively will be presented as means and standard deviations by treatment arm.

Secondary Endpoints
Inflammatory cytokine markers - IL-6, IL-8, TNF-alpha concentrations
Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total
Inflammatory markers - CRP concentrations
Blood draws during consultation, immediately prior to surgery, and at POD5, approximately 2-4 weeks total
Preoperative Anxiety
On the day of surgery prior to the procedure, approximately 2-4 weeks after enrollment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Experimental Treatment - MelatoninEXPERIMENTALPremedication for three nights with 10mg melatonin
Control Treatment - LactosePLACEBO_COMPARATORPremedication for three nights with lactose capsules
Interventions
NameTypeDescription
Melatonin 10 MGDRUG3 melatonin 10mg capsules will be given to the treatment arm
Lactose pillDRUG3 lactose pills will be provided to the control arm
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Eligibility Criteria
Age Range18 Years — 35 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction under IV sedation * Ages 18-35 * American Society of Anesthesiologists (ASA) Class I or II * English or Spanish speaking patients * Capacity to sign informed consent Exclusion Crite...

Countries:United States
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