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Tinidazole

Phase 2

Mycoplasma Genitalium | Small molecule | Infectious Disease |Hologic, Inc.|Last Updated: May 4, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Tinidazole · 1 trial · 2 indications

Phase 2 1
NCT07088419"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"Mycoplasma Genitalium
RECRUITING40 Analytics
PHASE2RECRUITING
"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"
Mycoplasma GenitaliumUnlock trial analytics

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 to 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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Frequently asked questions about Tinidazole

What is Tinidazole used for in Mycoplasma Genitalium?

Tinidazole is an investigational small molecule being studied for the treatment of Mycoplasma Genitalium, a sexually transmitted infection that can cause non-gonococcal urethritis (NGU). It is currently in Phase 2 clinical development and has not been approved for this indication.

What does Tinidazole target?

Tinidazole is a small molecule antibiotic. Its specific molecular target for Mycoplasma Genitalium is not disclosed in the available information. The drug is being evaluated for its ability to treat this infection, which is a common cause of non-gonococcal urethritis.

Who makes Tinidazole?

Tinidazole is being developed by Hologic, Inc., a company traded on the NASDAQ under the ticker HOLX. Hologic is conducting clinical trials to evaluate the drug's safety and efficacy for treating Mycoplasma Genitalium infections.

What phase is Tinidazole in?

Tinidazole is in Phase 2 clinical development for Mycoplasma Genitalium. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is actively recruiting participants in the United States.

What clinical trials is Tinidazole in?

Tinidazole is being studied in a single Phase 2 clinical trial with the identifier NCT07088419, titled "Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)". This trial is recruiting 40 male participants aged 18 years and older in the United States.

Is Tinidazole the same as other antibiotics?

Tinidazole is a distinct antibiotic agent. While it belongs to the nitroimidazole class of drugs, which includes other antibiotics like metronidazole, it is a separate compound. The available information does not list any alternative names for this drug.