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Bacterial Vaginosis

16
Pipeline Programs
17
Companies
24
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
6
0
5
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
5100%
+ 26 programs with unclassified modality

Competitive Landscape

17 companies ranked by most advanced pipeline stage

Human BioSciences
Human BioSciencesWV - Martinsburg
3 programs
1
1
NuvaRingPhase 41 trial
LACTIN-VPhase 2
hygienic information plus 62% ethyl alcohol in emollient gelN/A
Active Trials
NCT02445989Completed120Est. Dec 2018
BGI
BGIChina - Hong Kong
1 program
1
ProbioticsPhase 42 trials
Active Trials
NCT04771728Recruiting140Est. Dec 2026
NCT03894813Completed126Est. Dec 2020
Starpharma
StarpharmaAustralia - Abbotsford
5 programs
1
4
1% SPL7013 GelPhase 31 trial
1% SPL7013 GelPhase 31 trial
Metronidazole oral tablets 500mgPhase 31 trial
Metronidazole oral tablets 500mgPhase 31 trial
0.5% SPL7013 GelPhase 21 trial
Active Trials
NCT01201057Completed132Est. May 2011
NCT01577238Completed250Est. Jul 2012
NCT01577537Completed251Est. Oct 2012
+2 more trials
Daré Bioscience
Daré BioscienceCA - San Diego
2 programs
1
1
DARE-BV1clindamycin phosphate vaginal gel, 2%Phase 31 trial
DARE-BV1Phase 11 trial
Active Trials
NCT05354050Completed21Est. Dec 2020
NCT04370548Completed307Est. Dec 2020
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
4 programs
1
Menstrual CupPhase 21 trial
hygienic information plus 62% ethyl alcohol in emollient gelN/A1 trial
750 mg metronidazole/ 200 mg miconazole vaginal suppositoryPHASE_11 trial
Neo-Penotran® FortePHASE_21 trial
Active Trials
NCT00542074Completed223Est. Aug 2005
NCT02185456Unknown200Est. Mar 2016
NCT01230814Completed234Est. Aug 2013
+1 more trials
Osel
OselCA - Mountain View
3 programs
1
2
LACTIN-VPhase 21 trial
LACTIN-VPhase 2
Low dose LACTIN-V applicatorPhase 11 trial
Active Trials
NCT00537576Completed12Est. Apr 2008
NCT00635622Completed40Est. Jan 2009
Aurum Biosciences
Aurum BiosciencesUK - Glasgow
1 program
1
LACTIN-VPhase 21 trial
Active Trials
NCT05022212Completed45Est. Mar 2023
BioNTech
BioNTechCA - San Diego
1 program
1
BNT331Phase 11 trial
Active Trials
NCT06469164Completed102Est. Jul 2025
Mission Pharmacal
Mission PharmacalTX - San Antonio
2 programs
tinidazolePHASE_1Small Molecule1 trial
TinidazolePHASE_3Small Molecule1 trial
Active Trials
NCT00510614Completed37Est. Sep 2009
NCT00229216Completed200Est. Jun 2007
Mission Therapeutics
Mission TherapeuticsUK - Cambridge
2 programs
tinidazolePHASE_1Small Molecule
TinidazolePHASE_3Small Molecule
Roche
RocheSTAVANGER NORWAY, Norway
1 program
cobas® BV/CV testN/A
Genentech
GenentechCA - Oceanside
1 program
cobas® BV/CV testN/A1 trial
Active Trials
NCT06975436Completed738Est. Jun 2025
Otsuka
OtsukaJapan - Tokushima
1 program
cranberry juiceN/A1 trial
Active Trials
NCT00318253Completed12Est. Aug 2006
IBSS Biomed
IBSS BiomedPoland - Krakow
1 program
probioticN/A1 trial
Active Trials
NCT01993524Completed594Est. Feb 2012
Biomed
BiomedAustralia - Sydney
1 program
probioticN/A
Teva
TevaIsrael - Petach Tikva
1 program
MetronidazolePHASE_1_2Small Molecule1 trial
Active Trials
NCT01020396Completed579Est. Mar 2003
Parexel
ParexelMA - Boston
1 program
RIFAXIMIN VAGINAL TABLET 25 MGPHASE_2

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
BGIProbiotics
BGIProbiotics
Human BioSciencesNuvaRing
Daré BioscienceDARE-BV1clindamycin phosphate vaginal gel, 2%
StarpharmaMetronidazole oral tablets 500mg
StarpharmaMetronidazole oral tablets 500mg
Starpharma1% SPL7013 Gel
Starpharma1% SPL7013 Gel
Mission PharmacalTinidazole
Allergy TherapeuticsMenstrual Cup
Aurum BiosciencesLACTIN-V
Allergy TherapeuticsNeo-Penotran® Forte
Starpharma0.5% SPL7013 Gel
OselLACTIN-V
TevaMetronidazole

Showing 15 of 24 trials with date data

Clinical Trials (24)

Total enrollment: 5,994 patients across 24 trials

NCT04771728BGIProbiotics

A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Start: Feb 2020Est. completion: Dec 2026140 patients
Phase 4Recruiting
NCT03894813BGIProbiotics

Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Start: Mar 2019Est. completion: Dec 2020126 patients
Phase 4Completed
NCT02445989Human BioSciencesNuvaRing

Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity

Start: May 2016Est. completion: Dec 2018120 patients
Phase 4Completed
NCT04370548Daré BioscienceDARE-BV1clindamycin phosphate vaginal gel, 2%

DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)

Start: Jun 2020Est. completion: Dec 2020307 patients
Phase 3Completed
NCT02237950StarpharmaMetronidazole oral tablets 500mg

Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

Start: Oct 2014Est. completion: Feb 2017586 patients
Phase 3Completed
NCT02236156StarpharmaMetronidazole oral tablets 500mg

Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

Start: Oct 2014Est. completion: Oct 2016637 patients
Phase 3Completed
NCT01577537Starpharma1% SPL7013 Gel

A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

Start: Apr 2012Est. completion: Oct 2012251 patients
Phase 3Completed
NCT01577238Starpharma1% SPL7013 Gel

A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

Start: Mar 2012Est. completion: Jul 2012250 patients
Phase 3Completed
NCT00229216Mission PharmacalTinidazole

Treatment of Bacterial Vaginosis With Oral Tinidazole

Start: Jan 2005Est. completion: Jun 2007200 patients
Phase 3Completed
NCT05666778Allergy TherapeuticsMenstrual Cup

Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs

Start: Feb 2023Est. completion: Jul 2027408 patients
Phase 2Active Not Recruiting
NCT05022212Aurum BiosciencesLACTIN-V

Phase 2 Trial of LACTIN-V in Women at High Risk of HIV Acquisition

Start: May 2021Est. completion: Mar 202345 patients
Phase 2Completed
NCT01230814Allergy TherapeuticsNeo-Penotran® Forte

Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women

Start: Apr 2011Est. completion: Aug 2013234 patients
Phase 2Completed
NCT01201057Starpharma0.5% SPL7013 Gel

Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)

Start: Aug 2010Est. completion: May 2011132 patients
Phase 2Completed
NCT00635622OselLACTIN-V

Safety and Efficacy Study of Lactobacillus Administered Vaginally in Women With Bacterial Vaginosis

Start: Apr 2008Est. completion: Jan 200940 patients
Phase 2Completed
NCT01020396TevaMetronidazole

Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis

Start: Jan 2002Est. completion: Mar 2003579 patients
Phase 1/2Completed
NCT06469164BioNTechBNT331

A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis

Start: Jul 2024Est. completion: Jul 2025102 patients
Phase 1Completed
NCT05354050Daré BioscienceDARE-BV1

Pharmacokinetic Study of DARE-BV1

Start: Nov 2020Est. completion: Dec 202021 patients
Phase 1Completed
NCT02185456Allergy Therapeutics750 mg metronidazole/ 200 mg miconazole vaginal suppository

Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis

Start: Sep 2014Est. completion: Mar 2016200 patients
Phase 1Unknown
NCT00537576OselLow dose LACTIN-V applicator

Safety Study of Lactobacillus Administered Vaginally to Healthy Women

Start: Nov 2007Est. completion: Apr 200812 patients
Phase 1Completed
NCT00510614Mission Pharmacaltinidazole

Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

Start: Oct 2007Est. completion: Sep 200937 patients
Phase 1Completed
NCT06975436Genentechcobas® BV/CV test

Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis

Start: Dec 2024Est. completion: Jun 2025738 patients
N/ACompleted
NCT01993524IBSS Biomedprobiotic

Supplementation of Standard Antibiotic Therapy With Oral Probiotics for Bacterial Vaginosis

Start: Mar 2009Est. completion: Feb 2012594 patients
N/ACompleted
NCT00318253Otsukacranberry juice

The Effects of Cranberry Juice on Bacterial Adhesion

Start: Mar 2006Est. completion: Aug 200612 patients
N/ACompleted
NCT00542074Allergy Therapeuticshygienic information plus 62% ethyl alcohol in emollient gel

Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

Start: Jun 2003Est. completion: Aug 2005223 patients
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

5 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 5,994 patients
17 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.