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Developed by 
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Supported by 
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VH-310 (VH-4367310; cabotegravir stearate; XVIR-110)
Developer(s)
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Exavir Therapeutics Originator
https://www.exavirtherapeutics.com/#pipeline
United States Exavir Therapeutics is a biopharmaceutical company focused on developing ultra-long-acting therapeutics for chronic viral infections and CNS disorders. Headquartered in San Francisco, CA, they utilize prodrug nano-formulation technology to extend the half-life of drugs. Their current research focus primarily targets HIV, with the goal of improving treatment adherence and patient outcomes. |
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Drug structure
Cabotegravir Chemical Structure (Stearate not pictured)
Sourced from DrugBank
Drug information
Associated long-acting platforms
Aqueous drug particle suspension, Nanocrystal Suspension
Administration route
Intramuscular, Subcutaneous,
Therapeutic area(s)
Use case(s)
Use of drug
Ease of administration
Frequency of administration
User acceptance
Dosage
Available dose and strength
40 mg/kg; 75 mg/kg (Preclinical Tested doses)
Maximum dose
75 mg/kg
Recommended dosing regimen
VH-310 is formulated as a nanocrystalline intramuscular long-acting injectable suspension (XVIR-110) that has the potential to be dosed once or twice yearly in humans based on pharmacokinetic modelling. Preliminary preclinical data indicates once or twice yearly administration. 40 mg/kg or 75 mg/kg SC Single dose in preclinical studies.
Additional comments
The estimated elimination half-life of CAB from VH-310 is ~120 days (~17 weeks or ~4 months) and provided mean CAB concentrations greater than 10x & 4x the PB-IC90 for more than 6 months & 1 year.
Dosage link(s)
Drug information
Drug's link(s)
Not provided
Generic name
Brand name
Compound type
Drug class/category
Summary
Approval status
Regulatory authorities
Safety
Efficacy
Evidence Summary
Delivery device(s)
No delivery device
Scale-up and manufacturing prospects
Scale-up prospects
VH4367310 (VH-310), a cabotegravir (CAB) prodrug is currently in preclinical development, therefore detailed manufacturing and scale-up prospects are not currently available. One formulation (XVIR-110) is a nanocrystalline cabotegravir prodrug that achieves and maintains sustained cabotegravir exposures which support its ongoing development as a potential ultra-long-acting INSTI for HIV PrEP and in-combination for treatment.
Tentative equipment list for manufacturing
Currently unknown
Manufacturing
Currently unknown
Specific analytical instrument required for characterization of formulation
Currently unknown
Clinical trials
221875
Identifier
NCT07818915
Link
https://clinicaltrials.gov/study/NCT07818915
Phase
Phase I
Status
Not yet recruiting
Sponsor
ViiV Healthcare
More details
This study evaluates the PK, safety, and tolerability of a single increasing dose of VH4367310, a cabotegravir (CAB) prodrug, when administered intramuscularly in healthy adult participants 18 to 55 years of age.
Purpose
A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants
Interventions
Intervention 1
Intervention 2
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2026-09-15
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2026-09-08
Estimated Primary Completion Date
2029-01-02
Estimated Completion Date
2030-01-02
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
- Adults
Genders
- All
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied populations
Inclusion Criteria: * Participant must be greater than or equal to (\>=) 18 years and less than or equal to (\<=) 55 years of age, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation. * Body weight \>=40 kg and BMI within the range \>=18 to \<=32 kg/m\^2. * Participants may be male or female. Male participants are eligible to participate if they agree to the contraception requirements of the study during the study intervention period and for at least 90 days after the last dose of study intervention. Participants assigned female at birth are eligible to participate if they are a participant of non-childbearing potential (PONCBP). * Capable of giving written informed consent. Exclusion Criteria: * Current presence or his
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
112
Allocation
Randomized
Intervention model
Sequential assignment
Intervention model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
PrEP
Key resources
Excipients
Proprietary excipients used
Not provided
Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration
Not provided
Residual solvents used
Not provided
Patent info
Description
Crystalline form of cabotegravir stearate
Brief description
Crystalline form of cabotegravir stearate with high polymorphic purity and specific characterisation. Method of making said crystalline form and method of use for treatment of HIV
Representative patent
WO2025128496
Category
Salt/crystalline form
Patent holder
ViiV (licensed from Exavir)
Exclusivity
License agreement with Exavir
Expiration date
December 10, 2044
Status
National phase not entered yet, 30 months deadline on 12 June 2026
Description
Compositions of cabotegravir stearate
Brief description
Compositions of cabotegravir stearate formulated with poloxamer P338 and a stabilizer selected from the group consisting of sodium carboxymethylcellulose (NaCMC), polyvinylpyrrolidone (PVP), polyethylene glycol 3350 and polyethylene glycol 4000. Method of treatment and dosing regimen to treat HIV
Representative patent
WO2025128498
Category
Formulation, Method of treatment, Dosing Regimen
Patent holder
ViiV (licensed from Exavir)
Exclusivity
License agreement with Exavir
Expiration date
December 10, 2044
Status
National phase not entered yet, 30 months deadline on 12 June 2026
Description
Crystalline forms of cabotegravir stearate
Brief description
Crystalline forms of cabotegravir stearate, mixture of crystalline forms, and methods of using the same in the treatment of viral infections including HIV
Representative patent
WO2024196661
Category
Crystalline forms
Patent holder
Exavir Therapeutics, Inc.
Exclusivity
Not provided
Expiration date
March 13, 2044
Status
Not yet in National Phase, entry deadline on the 17.09.2025
Description
Compositions containing a crystalline form of cabotegravir stearate and a cryoprotectant
Brief description
Pharmaceutical compositions containing a crystalline form of cabotegravir stearate and a cryoprotectant, method using of injecting intramuscularly said composition to treat HIV infection, and process for preparation of said composition as a suspension
Representative patent
WO2024196662
Category
Composition
Patent holder
Exavir Therapeutics, Inc.
Exclusivity
Not provided
Expiration date
March 13, 2044
Status
Not yet in National Phase, entry deadline on the 17.09.2025
Description
Cabotegravir stearate nanoparticle and use to treat HIV
Brief description
Prodrug compound of cabotegravir and other integrase inhibitors, crystalline nanoparticle of said prodrug, and use thereof to treat HIV
Representative patent
WO2020086555
Category
Compound
Patent holder
Board of the Regents of the University of Nebraska
Exclusivity
Not provided
Expiration date
October 22, 2039
Status
Granted: CN, US, MX, EP (BE, CH, CY, DE, ES, FI, FR, GB, HU, IE, IT, LI, LU, MC, MT, NL, RO), SA, EA (AM, AZ, BY, KG, KZ, RU, TJ, TM) Pending: AU, BR, CA, EG, HK, ID, IL, JP, KR, MY, NZ, PH, SG Not in force: AT, BG, CZ, DK, EE, GR, HR, IS, LT, LV, NO, PT, RS, SE, SI, SK, SM, TR, IN, , KH, MA, MD, TN, BA, ME
Supporting material
Publications
There are no publication
Additional documents
No documents were uploaded