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Developed by 
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Supported by 
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VH-310 (VH-4367310)
Developer(s)
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Exavir Therapeutics, Inc. 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, To be determined
Therapeutic area(s)
Use case(s)
Use of drug
Ease of administration
Frequency of administration
User acceptance
To be determined
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
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
Not providedExcipients
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
Access principles
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Collaborate for developmentConsider 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 |
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Share technical information for match-making assessmentProvide 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 |
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Work with MPP to expand access in LMICsIn 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