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Developed by 
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Supported by 
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Cabotegravir Stearate (M2CAB)
Developer(s)
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Exavir Therapeutics, Inc. Originator
https://exavirtherapeutics.com/
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. |
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
Therapeutic area(s)
Use case(s)
Use of drug
Ease of administration
User acceptance
Not provided
Dosage
Available dose and strength
Not yet available
Frequency of administration
Preliminary preclinical data indicates once or twice yearly administration.
Maximum dose
Not yet available
Recommended dosing regimen
M2CAB 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
Additional comments
The estimated elimination half-life of CAB from XVIR-110 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
Summary
Approval status
Regulatory authorities
Delivery device(s)
No delivery device
Scale-up and manufacturing prospects
Scale-up prospects
Cabotegravir stearate (M2CAB) 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
Not provided
Manufacturing
Not provided
Specific analytical instrument required for characterization of formulation
Not provided
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
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
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