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ViiV Healthcare Originator
https://viivhealthcare.com/
United Kingdom ViiV Healthcare is a pharmaceutical company that specializes in the development of therapies for HIV infection. The company is headquartered in Brentford in the United Kingdom and was initially formed in November 2009 as a part of a joint venture between GlaxoSmithKline and Pfizer. |
Cabotegravir Chemical Structure
Sourced from Drugbank
Aqueous drug particle suspension
Subcutaneous, Intramuscular, To be determined
Not provided
Formulation is in clinical development but not yet approved or commercially available. Pharmacokinetic simulations predict that a 1600 mg/3mL IM dose would be sufficient for a Q4M dosing schedule.
Once every four months (Q4M)
1600 mg (2.7x CAB-LA)
Phase I trial evaluating safety and pharmacokinetic profile used doses at 800 mg, 1200 mg, and 1600 mg at four monthly intervals.
Not provided
Not provided
No delivery device
CAB-ULA is a novel formulation developed by ViiV Healthcare that doubles the concentration of cabotegravir, exhibits favourable tolerability and safety, with a PK profile that supports dose intervals of ≥4 months. Detailed manufacturing information regarding the new CAB-ULA formulation is not yet available.
Not provided
Not provided
Not provided
NCT06741397
https://clinicaltrials.gov/study/NCT06741397
Phase II
Recruiting
ViiV Healthcare
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)
Intervention 1
Intervention 2
Not provided
Anticipated Start Date
Not provided
Actual Start Date
2024-12-20
Anticipated Date of Last Follow-up
2025-02-17
Estimated Primary Completion Date
2026-09-22
Estimated Completion Date
2028-12-28
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
Yes
Inclusion Criteria: 1. At the time of obtaining informed consent, adolescent and adult participants weighing at least 35 kg. 2. Participants must have a nonreactive HIV test at Screening (rapid test, nonrapid HIV immunoassay, and HIV RNA) and enrollment (a rapid test, nonrapid HIV immunoassay, and HIV RNA). 3. Participants who are at risk of acquiring HIV, defined as having had anal or vaginal sex in the past 6 months. 4. Participants who are overtly healthy as determined by medical evaluation by a responsible and experienced physician, including medical history, physical examination, laboratory tests and cardiac monitoring at the time of screening. 5. No alcohol or substance use that, in the opinion of the study investigator and medical monitor, would interfere with the study.
Interventional (clinical trial)
200
Randomized
Single group assignment
Not provided
Open label
This is an open label study.
PrEP
NCT06786520
https://clinicaltrials.gov/study/NCT06786520
Phase I
Recruiting
ViiV Healthcare
This study will assess the pharmacokinetics (PK), safety, and tolerability of CAB ULA administered every 4 months (Q4M) following administration of CAB LA every 2 months (Q2M), in healthy adult volunteers.
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults
Intervention 1
Intervention 2
Not provided
Anticipated Start Date
Not provided
Actual Start Date
2025-01-17
Anticipated Date of Last Follow-up
2025-02-17
Estimated Primary Completion Date
2027-02-17
Estimated Completion Date
2028-02-29
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
Yes
Inclusion Criteria: * Adult participants greater than or equal to (\>=) 18 years old, weighing at least 35 kg. * Participants who are overtly healthy as determined by medical evaluation. * Assigned male sex at birth or assigned female sex at birth. Participants assigned female sex at birth are eligible to participate if they are of non-childbearing potential, or if they are of childbearing potential and are not pregnant (confirmed by test), not breastfeeding, and are using a highly effective contraceptive method. * Capable of giving written informed consent.
Interventional (clinical trial)
60
Not provided
Single group assignment
Not provided
Open label
None (Open Label)
PrEP
Not provided
Not provided
Not provided
There are either no relevant patents or these were not yet submitted to LAPaL
There are no publication
No documents were uploaded
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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 |
Not provided