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Drugbank

Pibrentasvir (P)

Developer(s)

AbbVie

Originator
https://www.abbvie.com/

United States

AbbVie Inc. is a global biopharmaceutical company that manufactures and develops innovative medicines as part of a diversified portfolio across several therapeutic categories including immunology, oncology, neuroscience, aesthetics and eyecare. Headquartered in North Chicago, Illinois, AbbVie was founded in 2013 following a successful corporate spin-off from its parent company Abbott Laboratories.

Drug structure

Pibrentasvir Chemical Structure

Pibrentasvir Chemical Structure

Drugbank

Glecaprevir Chemical Structure

Glecaprevir Chemical Structure

Drugbank

Drug information

Associated long-acting platforms

Aqueous drug particle suspension

Administration route

Oral

Therapeutic area(s)

HCV

Use case(s)

Treatment

Use of drug

Ease of administration

Administered by a community health worker
Administered by a nurse
Administered by a specialty health worker
Self-administered

Frequency of administration

Daily

User acceptance

Not provided

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

Drug information

Drug's link(s)

https://go.drugbank.com/drugs/DB13878

Generic name

Pibrentasvir

Brand name

Maviret, Mavyret (when associated with Pibrentasvir)

Compound type

Small molecule

Drug class/category

DAA

Summary

Glecaprevir and Pibrentasvir (G/P) is a fixed-dose combination therapy indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotypes 1-6 with or without compensated cirrhosis. G/P consists of two pangenotypic direct-acting antiviral agents: (1) Glecaprevir which targets the HCV non-structural viral protein 3/4A (NS3/4A) serine protease, and (2) Pibrentasvir which inhibits the HCV NS5A protein - both of which are essential for viral RNA replication and viron assembly. G/P is postulated to possess advantageous pharmacological properties - including suitable target plasma exposures, half-life duration and aqueous solubility - that could potentially enable the development of a cost-effective long-acting injectable formulation via particle-processing technologies.

Approval status

Glecaprevir and Pibrentasvir (G/P) oral fixed-dose combination is FDA approved

Regulatory authorities

Glecaprevir and Pibrentasvir (G/P) oral fixed-dose combination is FDA approved

Delivery device(s)

No delivery device

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

Clinical trials

Not provided

Excipients

Proprietary excipients used

No proprietary excipient used

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

No novel excipient or existing excipient used

Residual solvents used

No residual solvent used

Patent info

There are either no relevant patents or these were not yet submitted to LAPaL

Supporting material

Publications

There are no publication

Additional documents

No documents were uploaded

Useful links

There are no additional links

Access principles

Collaborate for development

Consider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology

Not provided

Share technical information for match-making assessment

Provide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit

Not provided

Work with MPP to expand access in LMICs

In the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing

Not provided

Comment & Information

Not provided