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First-in-line subcutaneous injectable for reversible, non-hormonal male contraception.

Sarah Anne Howard1, James K Tsuruta2, Andres Prieto Trujillo1

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Summary

Researchers developed a novel injectable male contraceptive using EP055 in an in-situ forming implant (ISFI). This non-hormonal option showed reversible contraceptive effects and was well-tolerated in mice, supporting future male contraception development.

Keywords:
EPPIN-inhibitorIn-situ forming implantMale ContraceptionNon-hormonal Contraception

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Area of Science:

  • Reproductive biology
  • Pharmacology
  • Biomaterials science

Background:

  • Current male contraceptive methods are limited to condoms and vasectomy.
  • There is a need for reversible, highly effective male contraceptive options.
  • EP055 is a novel non-hormonal compound with potential contraceptive effects.

Purpose of the Study:

  • To formulate EP055 into an in-situ forming implant (ISFI) for long-acting injectable male contraception.
  • To evaluate the safety, pharmacokinetics, and efficacy of the EP055-ISFI in male mice.

Main Methods:

  • Developed and optimized EP055-ISFI formulations.
  • Investigated in vitro release kinetics over 35 days.
  • Conducted in vivo studies in male BALB/c mice for safety, PK, and efficacy assessment.

Main Results:

  • Optimized EP055-ISFI (F.04) demonstrated sustained in vitro release.
  • In vivo studies showed EP055 ISFI elicited burst release followed by sustained plasma concentrations up to 28 days.
  • EP055 ISFI administration reduced sperm motility and increased premature acrosomal membrane degradation, indicating contraceptive efficacy.
  • The compound was well-tolerated with no systemic inflammation.

Conclusions:

  • EP055-ISFI is a promising long-acting injectable male contraceptive.
  • The formulation demonstrated reversible contraceptive effects and good safety profile in mice.
  • Results support further development of EPPIN-targeting molecules and ISFIs for male contraception.