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Drug information

Drug's link(s)

Not provided

Generic name

VH-4011499

Brand names

Not provided

Compound type

Small molecule

Drug class/category

HIV-1 Capsid inhibitor

Summary

VH-499 is an investigational drug currently in clinical development for long-acting HIV-1 treatment and pre-exposure prophylaxis. It functions via a multistage mechanism of action inhibiting both early and late HIV-1 replication. VH-499 has shown potent antiviral activity against a broad range of HIV-1 lab strains and clinical isolates at picomolar EC50 levels. Pre-existing resistance to this inhibitor is thought to have a low likelihood. The geometric mean half-life was estimated to have a range 51-66 hours. Interim results of NCT06724640 shows that median time to maximum VH-499 concentration (tmax) was approximately 7 to 18 days post-dose for IM; tmax was approximately 112 days post-dose for SC due to slower absorption. Maximum VH-499 concentrations were lower for SC compared to IM.

Approval status

Compound is currently in clinical development and not yet approved in any jurisdiction.

Regulatory authorities

Not approved yet.

Therapeutic area(s)

  • HIV
Use case(s)
  • Pre-Exposure Prophylaxis (PrEP)
  • Treatment
  • Prevention

Administration route

Subcutaneous, Intramuscular, Oral

Associated long-acting platforms

Unknown

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
  • Every 6 months
  • Yearly
  • Every 4 months
User acceptance
In the Phase 1 trial, injection site pain of Grade 1 or Grade 2 severity was reported in 75% of participants who received VH-499. No serious adverse events (SAEs) were reported.

Dosage

Available dose and strength

100, 200, and 400 mg IM or SC

Maximum dose

VH-499 400 mg long-acting injection (IM or SC)

Recommended dosing regimen

VH-4011499 is 100 mg, 200 mg, or 400 mg, administered via subcutaneous (SC) or intramuscular (IM) injection.

Additional comments

The recommended dose and dosing regimen were derived from the interim results of clinical trial NCT06724640.

Dosage link(s)

Not provided

Associated compounds, formulations and regimens

Not provided

Associated technologies

Not provided

Additional information

Not provided

Developer(s)

ViiV Healthcare
Originator
United Kingdom

ViiV Healthcare

ViiV Healthcare (ViiV), a subsidiary of GSK plc, is a research company. It researches and develops the use of HIV medicines. The company offers nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, and CCR5 antagonists for the treatment of HIV.

Shionogi
Originator
Japan

Shionogi

From 20 January 2026, Shionogi & Co will hold subsidary stake in ViiV healthcare ltd. Shinogi is a drug discovery-based pharmaceutical company to create innovative products and services and to deliver value in collaboration with a diverse array of partners.

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

Not provided

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

Not provided

Residual solvents used

Not provided

Delivery device(s)

Not provided

Safety, Efficacy and Evidence Summary

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided

Description

Dezecapavir (formula Id) composition solution, comprising PEG

Brief description

A pharmaceutical composition comprising the compound of Formula Ia, Formula Ib, Formula Ic, or Formula Id, or a pharmaceutically acceptable salt thereof, is set forth. (Formula Ia), (Formula Ib), (Formula Ic), (Formula Id)

Representative patent

WO2021209900

Category

Formulation

Patent holder

VIIV HEALTHCARE UK

Exclusivity

Not provided

Expiration date

April 13, 2041

Status

Pending: AU, BR, CA, CL, CN, EP, IL, JP, KR, MY, MX, RU, ZA, US, VN

Description

Dezecapavir (VH4011499) compound

Brief description

The invention relates to compounds, compositions, and methods for the treatment of human immunodeficiency virus (HIV) infection. More particularly, the invention provides novel inhibitors of HIV, pharmaceutical compositions containing such compounds, and methods for using these compounds in the treatment of HIV infection. The invention also relates to methods for making the compounds hereinafter described.

Representative patent

WO2020254985

Category

Compound

Patent holder

VIIV HEALTHCARE UK

Exclusivity

Not provided

Expiration date

June 17, 2040

Status

Granted: AU, CN, DZ, EA (AM, AZ, BY, KG, KZ, TJ, TM), EP (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR, BA, ME, MA, MD), IL, IN, MX, NG, RU, SG, UA, US Pending: AR, BR, CA, CL, CO, CR, DO, EG, GC, HK, ID, JP, KR, MY, NZ, PK, PA, PE, PH, ZA, TW, TH, TT, UY, VE, VN