access-principles-1access-principles-2access-principles-3backcarrierdevelopmentease_of_administrationexportimplantableinjectablenon-implantablenon_carriernon_injectableother_featuresprintroute_of_administrationtherapeutic_areatype_of_tech

Drug information

Drug's link(s)

Not provided

Generic name

Glecaprevir Pibrentasvir LAI

Brand names

Not provided

Compound type

Small molecule

Drug class/category

antivirals

Summary

Not provided

Approval status

Unknown

Regulatory authorities

Unknown

Therapeutic area(s)

  • HCV
Use case(s)
  • Treatment

Administration route

Subcutaneous, Intramuscular, Route of administration of the injectable formulation is being determined in the clinical program

Associated long-acting platforms

Aqueous drug particle suspension

Use of drug

Ease of administration
  • Administered by a community health worker
  • Administered by a nurse
  • Administered by a specialty health worker
  • To be determined
Frequency of administration
  • Other/Variable/Unknown : To be determined based on clinical development
  • Once
User acceptance
To be determined

Dosage

Available dose and strength

Not provided

Maximum dose

Not provided

Recommended dosing regimen

Not provided

Additional comments

Not provided

Dosage link(s)

Not provided

Associated compounds, formulations and regimens

Associated compounds
Compare

Glecaprevir (G)
Pibrentasvir (P)

Associated technologies

Not provided

Additional information

Not provided

Developer(s)

Tandem Nano
Originator
United Kingdom

Tandem Nano

Drug structure

Scale-up and manufacturing prospects

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

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

Safety, Efficacy and Evidence Summary

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided

Description

long acting injectable liquid formulations comprising an aqueous dispersion of microparticles of glecaprevir and/or pibrentasvir stabilised by a first excipient and a second excipient.

Brief description

The present invention relates to long acting injectable liquid formulations comprising an aqueous dispersion of microparticles of glecaprevir and/or pibrentasvir stabilised by a first excipient and a second excipient. The present invention also relates to solid compositions which may be used as a precursor for the long acting injectable formulations, aqueous dispersions, microneedle arrays, implantable rods, and pharmaceutical compositions, methods of producing such long acting injectable formulations, and medical uses for such formulations and methods of treatment using such formulations.

Representative patent

WO2023052776

Category

Formulation

Patent holder

University of Liverpool

Exclusivity

Not provided

Expiration date

September 29, 2042

Status

Pending in EP, IN, US and CN