Refillable Nanofluidic Subcutaneous Implant
ENG + ISL NanoMPI
- User: Female
- Hormonal: Hormonal
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Delivery type:
- Subdermal
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Intended Duration:
- Long-Acting
- Development Stage: Pre-Clinical
- Developer(s)/researcher(s): University of Washington, Methodist Hospital Research Institute
Details
- API: Etonogestrel, Islatravir
- Target: Progesterone Receptor
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Mechanism of Action:
- Endometrial Changes
- Cervical Mucus Changes
- Ovulation Inhibition
- Anti-Microbial
- Inactive Materials: Not Yet Determined
- Regimen: Not Yet Determined
- MPT: Potential MPT
- Promising Attributes: The method offers both pregnancy prevention and HIV prevention and can be used discreetly.
Product Status
Active Pre-Clinical Research
History
An NIH grant was awarded in 2023 1) to develop optimized ENG-ISL drugamer formulations that stabilize the drugs and exhibit the desired zero order release profiles, in concert with the optimization of the NanoMPI device for 2-year sustained release; 2) to assess pharmacokinetics, tolerability, and safety of the lead ENG-ISL NanoMPI device for 2 years in pigtail macaques; and 3) to evaluate contraception and HIV PrEP efficacy of ENG-ISL NanoMPI in pigtail macaques via repeated low-dose vaginal challenge and develop a PK/PD model. Funding was renewed in 2024 and 2025.
In 2025, the Houston Methodist Research Institute released results of macaque studies on a ISL-only nanofluidic refillable subcutaneous implant (no contraceptive API), which indicated the delivery system's potential for sustained release of ARV drugs for HIV treatment. Development of ISL as a preventative, rather than a therapeutic, is currently globally discontinued due to its negative impact on lymphcyte and CD4 concentration in healthy patients, definitively identified in 2024. This may impact the final profile and indication for this product.