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Verified by the innovator, on Jul 2021

Technology name

Last update: Jul 2026

Drug Combination Nanoparticles (DcNP)

Sponsor(s)

export_notes
Verified by the innovator, on Jul 2021

Type of technology

Based on other organic particles, Aqueous drug particle suspension

Administration route

Subcutaneous

Development state and regulatory approval

Active Pharmaceutical Ingredient (API)

Lamivudine (3TC), Dolutegravir (DTG), Tenofovir (TFV)

Development Stage

Phase I

Regulatory Approval

Not provided

Description

A targeted and long-acting Drug combination Nano-Particle (DcNP) platform that enables transformations of existing and new drug entities from short-acting daily doses to a long-acting drug combination for a maximum therapeutic effect through sustained viral suppression. Developed by Targeted & Long-acting drug Combination (TLC) Program at University of Washington.

Developer(s)

University of Washington
Originator
United States

University of Washington

The purpose of the Targeted Long-acting Combination AntiRetroviral Therapy (TLC-ART) program is to develop one or more safe, stable, scalable and tolerable long acting antiretroviral combinations for treatment of HIV infection.

Technology highlight

TLC's enabling DcNP technology has been validated to work with a number of current HIV drug combinations using clinics in both pediatric and adult populations. A number of these formulations have been evaluated in non-human primate models to provide both plasma and cell drug levels that persist for weeks after a single subcutaneous injection. This technology has been shown to bring together water soluble (such as tenofovir and lamivudine) and insoluble (such as lopinavir, ritonavir, atezenovir, and dolutegravir) drugs into an all-in-one long-acting injectable product. At least 4 formulations have been tested in NHP to have long-acting plasmakinetics for all drugs and are targeted to enhanced drug levels above plasma drug combinations in HIV host cells-PBMCs.

Illustration(s)

Technology main components

Drug API and common lipid excipients used in pharmaceutical formulations.

Information on the raw materials sourcing, availability and anticipated price

The existing HIV drug APIs can be sourced through WHO pre-qualified raw material suppliers.

Safety, Efficacy and Evidence Summary

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided

APIs compatibility profile

API desired features
Water-soluble molecules

Water-insoluble molecules

Small molecules

Tenofovir, Lamivudine, Dolutegravir, Lopinavir, Ritonavir, Atazanavir, Efavirenz

Additional solubility data

Not provided

Additional stability data

Not provided

API loading: Maximum drug quantity to be loaded

10-30 wt%

API co-administration

4 different APIs : 2 to 4 different drugs in a single injection are being investigated

LogP

Not provided

Scale-up and manufacturing prospects

Scale-up prospects

Good

Tentative equipment list for manufacturing

Spray-dryer; homogenization; size-reduction

Manufacturing

Injectable cGMP facilties

Specific analytical instrument required for characterization of formulation

Not provided

Excipients & delivery device(s)

Proprietary excipients used

No proprietary excipient used

Novel excipients or existing excipients at a concentration above Inactive Ingredient Database (IID) for the specified route of administration

No novel excipient or existing excipient used

Residual solvents used

No residual solvent used

Delivery device(s)

No delivery device

Additional features

Other features of the technology
  • Biodegradable
  • Non-removable
  • Room temperature storage
  • At least 1 year shelf life
Release properties

Intracellular uptake and accessible by cellular enzymes to transform into active metabolites such as TFV-DP and 3TC-TP.

Injectability

Not provided

Stability

Not provided

Storage conditions and cold-chain related features

No cold-chain needed

Therapeutic area(s)

  • HIV
Use case(s)
  • Treatment

Potential associated API(s)

Use of technology

Ease of administration
  • Administered by a community health worker
  • Administered by a nurse
  • Administered by a specialty health worker
  • Self-administered
Frequency of administration

Monthly

User acceptance
Not provided

Targeted user groups

Age Cohort
  • Adults
Genders
  • Male
  • Female
  • Cisgender female
  • Cisgender male
  • Transgender female
  • Transgender male
  • Intersex
  • Gender non-binary
  • All
Pregnant individuals

Unspecified

Lactating individuals

Unspecified

Healthy individuals

No

Comment

Not provided

Lamivudine (3TC) , Dolutegravir (DTG) , Tenofovir (TFV)

Class(es)

Antiviral

Development stage

Phase I

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Treatment for people living with HIV

Foreseen user group

People living with HIV

Foreseen duration between application(s)

1 month

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Not provided

Lopinavir and ritonavir (LPV/r) , Tenofovir (TFV)

Class(es)

antiviral

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Treatment for people living with HIV to provide sustained viral suppression

Foreseen user group

People living with HIV

Foreseen duration between application(s)

1 month

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Not provided

Class(es)

Not provided

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

HIV treatment

Foreseen user group

Adults living with HIV

Foreseen duration between application(s)

1 month

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Not provided

All sponsors

Additional information