View source for LACTIN-V

{{Infobox drug
| drug_name         =
| INN               =
| type              = <!-- empty -->
| image             =
| alt               =
| caption           =
<!-- Clinical data -->
| pronounce         =
| tradename         =
| Drugs.com         =
| MedlinePlus       =
| pregnancy_AU      = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU_comment =
| pregnancy_category =
| routes_of_administration =
| ATCvet            =
| ATC_prefix        = <!-- 'none' if uncategorised -->
| ATC_suffix        =
<!-- Legal status -->
| legal_AU          = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| legal_AU_comment  =
| legal_BR          = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR_comment  =
| legal_CA          = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_CA_comment  =
| legal_DE          = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment  =
| legal_NZ          = <!-- Class A, B, C -->
| legal_NZ_comment  =
| legal_UK          = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C -->
| legal_UK_comment  =
| legal_US          = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| legal_US_comment  =
| legal_EU          =
| legal_EU_comment  =
| legal_UN          = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment  =
| legal_status      = Investigational
<!-- Pharmacokinetic data -->
| bioavailability   =
| protein_bound     =
| metabolism        =
| metabolites       =
| onset             =
| elimination_half-life =
| duration_of_action =
| excretion         =
<!-- Identifiers -->
| CAS_number        =
| PubChem           =
| PubChemSubstance  = 482028468
| UNII              = RP8X0ZB061
| DrugBank          = DB19093
| synonyms          = CTV-05; CTV05; ''Lactobacillus crispatus'' CTV-05
<!-- Chemical and physical data -->
| IUPAC_name        =
| chemical_formula  =
}}
'''LACTIN-V''', also known as '''CTV-05''' or as '''''Lactobacillus crispatus'' CTV-05''', is a [[live biopharmaceutical]] medication containing a strain of ''[[Lactobacillus crispatus]]'' (''L. crispatus'') which is under development for the treatment of [[urinary tract infection]]s (UTIs) and [[bacterial vaginosis]] (BV).<ref name="AdisInsight">{{cite web | url = https://adisinsight.springer.com/drugs/800013396 | title = CTV 05 | publisher = Adis Insight }}</ref><ref name="pmid33330916">{{cite journal | vauthors = Lagenaur LA, Hemmerling A, Chiu C, Miller S, Lee PP, Cohen CR, Parks TP | title = Connecting the Dots: Translating the Vaginal Microbiome Into a Drug | journal = J Infect Dis | volume = 223 | issue = 12 Suppl 2 | pages = S296–S306 | date = June 2021 | pmid = 33330916 | pmc = 8502429 | doi = 10.1093/infdis/jiaa676 | url = }}</ref> It is administered [[intravaginal administration|intravaginally]] and is described as the first [[vaginal microbiome]] (VMB)-based [[live biotherapeutic product]] (LBP).<ref name="pmid33330916" />
Depletion of [[hydrogen peroxide]] (H<sub>2</sub>O<sub>2</sub>)-producing ''[[Lactobacillus]]'' strains such as ''Lactobacillus crispatus'' in the [[vagina]] has been strongly associated with BV and UTIs.<ref name="pmid33330916" /> Most commercially available [[probiotic]] ''Lactobacillus'' strains are not vaginal strains and do not appear to improve vaginal or urinary health outcomes.<ref name="pmid33330916" /> The [[Centers for Disease Control and Prevention]] (CDC)'s ''Sexually Transmitted Infections Treatment Guidelines'' (2021) noted that intravaginal LACTIN-V produced a considerably lower recurrence of BV following initial [[antibiotic]] treatment with [[metronidazole]] in a [[randomized controlled trial]].<ref name="CDC2021">{{Cite web|url=https://www.cdc.gov/std/treatment-guidelines/bv.htm|title=Bacterial Vaginosis - STI Treatment Guidelines|date=July 19, 2021|website=www.cdc.gov}}</ref><ref name="pmid32402161">{{cite journal | vauthors = Cohen CR, Wierzbicki MR, French AL, Morris S, Newmann S, Reno H, Green L, Miller S, Powell J, Parks T, Hemmerling A | title = Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis | journal = N Engl J Med | volume = 382 | issue = 20 | pages = 1906–1915 | date = May 2020 | pmid = 32402161 | pmc = 7362958 | doi = 10.1056/NEJMoa1915254 | url = }}</ref> However, the guidelines also noted that LACTIN-V is not yet [[Food and Drug Administration]] (FDA)-approved or commercially available.<ref name="CDC2021" />
As of December 2021, LACTIN-V is in [[Phases of clinical research#Phase II|phase 2]]/[[Phases of clinical research#Phase III|3]] [[clinical trial]]s for the treatment of UTIs and is in phase 2 trials for the treatment of BV.<ref name="AdisInsight" /> It was originated by GyneLogix and is under development by Osel Inc., the [[National Institute of Allergy and Infectious Diseases]], and other organizations.<ref name="AdisInsight" />
==See also==
* [[TOL-463]]
==References==
{{Reflist}}
==External links==
* [https://adisinsight.springer.com/drugs/800013396 CTV-05 (LACTIN-V; Lactobacillus crispatus CTV-05) - AdisInsight]
* [https://synapse.patsnap.com/drug/567d85fd12b54f1ea9fb88ac70eff025 CTV-05 (LACTIN-V, Lactobacillus crispatus CTV-05, CTV 05) - Synapse]
[[Category:Experimental urogynecological drugs]]
[[Category:Lactobacillaceae]]
[[Category:Probiotics]]
{{Antiinfective-drug-stub}}
{{Genito-urinary-drug-stub}}