Technology name
Last update: Feb 2025Ultra-Long-Acting Multi-Purpose In-situ Forming Implant (ISFI)
Developer(s)
Sponsor(s)
Type of technology
In-situ forming gel/implant
Administration route
Subcutaneous
Development state and regulatory approval
Cabotegravir (CAB), Medroxyprogesterone acetate (MPA)
Pre-clinical
Not provided
Description
The in-situ forming implant (ISFI) consists of a liquid co-formulation utilizing excipients that form a biodegradable depot after subcutaneous injection for a controlled sustained release of active ingredients. It is based on a biodegradable polymer such as PLGA, a water miscible organic solvent such as NMP and the API or combination APIs of interest.
Developer(s)
University of North Carolina at Chapel Hill
Harnessing engineering, chemistry, and pharmacology tools to design and engineer innovative drug delivery platform technologies for disease treatment and prevention.
Technology highlight
First-in-line, ultra-long-acting injectable MPT that offers durable and sustained protection from HIV transmission, high efficacy of contraception, increased user compliance, and the ability to be removed if required. The ISFI offers at least 3 months sustained release after a single subcutaneous administration. It is biodegradable yet removable in case of adverse events or need for treatment reversibility.
Illustration(s)
Technology main components
poly(DL-lactide-co-glycolide) (PLGA), N-methyl-2-pyrrolidone (NMP), dimethyl sulfoxide (DMSO)
Polymers readily available on the market
Safety, Efficacy and Evidence Summary
Absence of adverse local or systemic inflammation when administered to mice or non-human primates
Not provided
Not provided
Not provided
APIs compatibility profile
Dolutegravir (DTG), Cabotegravir (CAB), Rilpivirine (RPV)
Confidential
Confidential
Not provided
Not provided
To be provided
2 different APIs : at least 2 different APIs
Not provided
Scale-up and manufacturing prospects
To be determined
To be determined
To be determined
To be determined
Excipients & delivery device(s)
No proprietary excipient used
No novel excipient or existing excipient used
No residual solvent used
No delivery device
Additional features
- Biodegradable
- Drug-eluting
- Monolithic
- Removable
- Single-use
- Room temperature storage
- At least 1 year shelf life
- Needs insertion kit
Zero order release
26-16 gauge needles
To be determined
To be determined
Therapeutic area(s)
- Contraception
- Multipurpose technology : "HIV PrEP and contraception"
- Diabetes
- HBV
- TB
- COVID 19
- HIV
- Pain management
- Oncology
- Pre-Exposure Prophylaxis (PrEP)
- Treatment
Potential associated API(s)
- Cabotegravir (CAB) , Medroxyprogesterone acetate (MPA)
- Cabotegravir (CAB) , Etonogestrel (ENG)
- Dolutegravir (DTG) , Medroxyprogesterone acetate (MPA)
- Dolutegravir (DTG) , Etonogestrel (ENG)
Use of technology
- Administered by a nurse
- Administered by a specialty health worker
- To be determined
To be determined
Targeted user groups
- Adults
- All
- Male
- Female
- Cisgender female
- Cisgender male
- Transgender female
- Transgender male
- Intersex
- Gender non-binary
Yes
Yes
Unspecified
Not provided
Cabotegravir (CAB) , Medroxyprogesterone acetate (MPA)
Not provided
Pre-clinical
Not provided
Not provided
Not provided
Not provided
Not provided
Cabotegravir (CAB) , Etonogestrel (ENG)
Not provided
Pre-clinical
Not provided
Not provided
Not provided
Not provided
Not provided
Dolutegravir (DTG) , Medroxyprogesterone acetate (MPA)
Not provided
Pre-clinical
Not provided
Not provided
Not provided
Not provided
Not provided
Dolutegravir (DTG) , Etonogestrel (ENG)
Not provided
Pre-clinical
Not provided
Not provided
Not provided
Not provided
Not provided