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Tinidazole

Phase 2

Mycoplasma Genitalium | Small molecule | Other |Hologic, Inc.|Last Updated: May 4, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07088419"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"PHASE2 RECRUITING 40Jul 23, 2025Aug 31, 2026May 4, 20261 United States
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Study Endpoints
Primary Endpoints
Microbiologic cure of M. genitalium
Day 38

Microbiologic cure of M. genitalium will be determined at a test of cure visit. Microbiologic cure will be defined as a negative test for M. genitalium in a urine specimen using a nucleic acid amplification test.

Secondary Endpoints
Antimicrobial susceptibility to tinidazole (MIC levels)
baseline; day 7; day 38
Antimicrobial susceptibility to tinidazole (resistance associated mutations)
baseline; day 7; day 38
Association of high MIC levels with treatment failure
Day 38
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TinidazoleEXPERIMENTALSingle Arm
Interventions
NameTypeDescription
TinidazoleDRUG2 grams orally on day one followed by 500mg orally twice daily on days 2-10
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * ≥18 years of age * Clinical diagnosis of NGU * Urogenital MG documented by a positive NAAT in the prior 7 days * Fluent in English * Assigned male at birth * Attending the PHSKC SHC * Able to provide informed consent * Able to undergo a test of cure (TOC) 21 days after complet...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07088419primaryCompletionDate: changed
LOWMay 24, 2026NCT07088419studyFirstPostDate: changed