No, LACTIN-V is not available for sale. It is an investigational drug that has not yet been approved by the FDA.

LACTIN-V will not be available until Phase 3 clinical development is completed and marketing authorization has been granted by the FDA.  LACTIN-V will then be available as a prescription product. 

LACTIN-V is a live biotherapeutic product (LBP) containing the live bacterium Lactobacillus crispatus CTV-05, a naturally occurring member of the human vaginal microbiome. LBP is defined by the FDA as a biologic drug that contains live microorganisms for the prevention, treatment, or cure of a disease or condition of human beings, and not a vaccine. 

LACTIN-V is an LBP, not a probiotic. LBPs are regulated as biologic drugs by the FDA. To be approved, they must be safe and effective for their intended use, i.e. to treat or prevent a specific disease indication, and manufactured under strict drug standards.

Many probiotics are sold as dietary supplements, which do not require FDA approval before they are marketed. Dietary supplement labels are not allowed to make specific health claims.

The vaginal microbiota is an ecosystem that is generally dominated by several specific Lactobacillus species.  Lactobacilli play a crucial role in women’s genitourinary and reproductive health by producing lactic acid and reducing the pH of the vagina. The acidic conditions are primarily responsible for preventing vaginal infections. Women with a diverse vaginal microbiota with depleted lactobacilli (dysbiosis) have a higher vaginal pH and a greater risk of bacterial vaginosis (BV), pelvic inflammatory disease (PID), sexually transmitted infections (STIs), including HIV and HPV, and pregnancy complications such as preterm birth (PTB).  Dysbiosis is also associated with inflammation of the female reproductive tract and disruption of the mucosal epithelial barrier. Conversely, women with a Lactobacillus crispatus dominated microbiota have the lowest vaginal pH and lowest risk of BV, STIs, and PTB.  They also have the lowest levels of pro-inflammatory mediators and epithelial barrier disruption.

Currently, there are no ongoing LACTIN-V clinical trials. When a new clinical trial is started, information about the trial will be posted on this website under News and a link to Clinicaltrials.gov will be provided. The Clinicaltrials.gov link will contain eligibility criteria, location of the clinical study sites, and contact information to learn more about participation in the trial.  

Currently, CBM588 capsules are being tested in patients with advanced kidney cancer at the City of Hope Comprehensive Cancer Center in Duarte, CA. Use the link NCT06399419 at clinicaltrials.gov for contact information.

Not in the U.S. CBM588 is an investigational drug under an IND with the FDA. CBM588 containing products cannot legally be marketed in the U.S. Direct-to-consumer CBM588 products are available in Japan as probiotics (e.g. Miyarisan Strong Tablets) and have appeared in online shopping sites in the U.S, U.K., and Europe. It should be noted that these products are approximately 100-fold less potent than the CBM588 product used in the kidney cancer trials conducted in the U.S.