Yaso Gel
PPCM Vaginal Gel
- User: Female
- Hormonal: Non-Hormonal
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Delivery type:
- Vaginal Gel
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Intended Duration:
- Pericoital
- Development Stage: Phase I
- Developer(s)/researcher(s): Yaso Therapeutics, NIAID, Albert Einstein College of Medicine, University of Illinois at Chicago, University of Texas Medical Branch, NICHD, University of Pittsburgh, Magee-Womens Research Institute
Details
- API: Poly-[1, 4-Phenylene-(1-Carboxy) Methylene] (PPCM)
- Target: Not Yet Determined
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Mechanism of Action:
- Inhibition of Sperm Capacitation
- Other
- Inactive Materials: CMC, Xanthan Gum, Propylene Glycol, Water
- Regimen: On Demand
- MPT: Potential MPT
- Promising Attributes: Spermicidal gels may meet consistent user demand for user-controlled, non-hormonal pericoital methods. Developer indicates that the gel exhibits excellent activity against HSV, HIV, N. gonorrhoeae, & Ebola virus.
Product Status
Active/Recent Clinical Evaluation
History
2002: Rush University publishes first pre-clinical evidence indicating a specific potential contraceptive use for mandelic acid condensation polymer (SAMMA). The polymer was already considered a viable anti-microbial. SAMMA would later be re-designated as poly-[1, 4-phenylene-(1-carboxy) methylene] (PPCM).
2007: NIH initiates support of product through 1R41AI069659-01, funding formulation, safety, and efficacy evaluation intended to lead to submission of an IND. NIH support would continue through 2025, facilitating development from bench research to a successful IND and initiation of a first in human trial.
2009: Additional evaluation clarifies mechanism of action, and publication by Rush Medical Center recommends further formulation development for an improved contraceptive microbicide.
2020: Development update publication confirms ongoing development by Yaso Therapeutics team of MPT containing PPCM
2020-2023: Evaluation by Yaso Therapeutics and collaborating institutions indicates that PPCM exhibits consistent activity against SARS-CoV-2, Ebola virus, and N. gonorrhoeae.
2021: In vitro evaluation finds consistent and rapid sperm deactivation from "actual use" concentrations of PPCM when measured through both acrosome staining and a hyaluronan binding assay.
2025: Yaso Therapeutics announces receipt of additional NIH funding to support first in human clinical trial of Yaso Gel, an MPT containing PPCM.