Recent Updates
Recently added Catalysts

Cabotegravir Formulation F

Phase 1

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Feb 6, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

Cabotegravir Formulation F · 1 trial · 1 indication

Phase 1 1
NCT06033547A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult ParticipantsHIV Infections
COMPLETED56 Analytics
PHASE1COMPLETED
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants
HIV Infections
NCT0603354756
Unlock trial analytics

Study Endpoints

Primary Endpoints

Maximum observed plasma concentration (Cmax) of cabotegravir
Up to Week 52
Time of maximum observed plasma concentration (tmax) of cabotegravir
Up to Week 52
Area under the concentration - time curve from time zero to 4 weeks following the injection (AUC[0-4]) of cabotegravir
Up to Week 4
Plasma Concentration of cabotegravir at Week 4
Week 4
Number of participants with adverse events (AEs) based on severity
Up to Week 52
Absolute value of haematology parameter: Platelet count (cells per microliter)
Up to Week 52
Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Up to Week 52
Absolute values of haematology parameters: haemoglobin (Hgb) (grams per decilitre)
Up to Week 52
Absolute values of haematology parameters: haematocrit (Proportion of red blood cells in blood)
Up to Week 52
Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Up to Week 52
Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
Up to Week 52
Absolute values of haematology parameters: Reticulocytes (Percentage of reticulocytes)
Up to Week 52
Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Up to Week 52
Absolute values of Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Up to Week 52
Absolute values of Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Up to Week 52

Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed.

Absolute values of Clinical chemistry parameters: Total Protein (Grams per deciliter)
Up to Week 52
Absolute values of Clinical chemistry parameters: Estimated Glomerular Filtration Rate (eGFR2) (millilitres per minute)
Up to Week 52
Change from Baseline in haematology parameter: Platelet count (cells per microliter)
Baseline (Day 1) and up to Week 52
Change from Baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood)
Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameters: Reticulocytes (Percentage of reticulocytes)
Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Baseline (Day 1) and up to Week 52
Change from baseline in Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Baseline (Day 1) and up to Week 52
Change from baseline in Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Baseline (Day 1) and up to Week 52

Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed

Change from baseline in Clinical chemistry parameters: Total Protein (Grams per deciliter)
Baseline (Day 1) and up to Week 52
Change from baseline in Clinical chemistry parameters: Estimated Glomerular Filtration Rate (eGFR) (millilitres per minute)
Baseline (Day 1) and up to Week 52

Secondary Endpoints

Area under the concentration - time curve from time zero to infinity (AUC[0-inf]) of cabotegravir
Up to Week 52
Area under the concentration - time curve from time zero to time of last quantifiable concentration [AUC(0-last)] of cabotegravir
Up to Week 52
Plasma Concentration of cabotegravir at Week 8,12 and 24
Week 8, 12 and 24
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Participants receiving Cabotegravir Formulation FEXPERIMENTAL -
Part B: Participants receiving Cabotegravir Formulation GEXPERIMENTAL -

Interventions

NameTypeDescription
Cabotegravir Formulation FDRUGCabotegravir Formulation F will be administered
Cabotegravir Formulation GDRUGCabotegravir Formulation G will be administered
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring * Body weight =\>40 kilogram (kg) and body mass index (BMI) within the range =\>18 to =\<32 kilogram per meter squ...

Countries:United States
Unlock Eligibility Criteria

Competitive Landscape -Bacterial Infections 61 trials (matched to "HIV Infections")

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
GSK plc Sponsored ADRGSK4PHASE2MenABCWY vaccine
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline/kg
BiomX Inc.PHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
Moderna, Inc.MRNA1PHASE2mRNA-1982
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 - AIGIV
Abbott LaboratoriesABT1N/AUndisclosed
CareDx, Inc.CDNA1 - Undisclosed
Unlock Competitive Intelligence

Frequently asked questions about Cabotegravir Formulation F

What is Cabotegravir Formulation F used for?

Cabotegravir Formulation F is an investigational small molecule being developed for HIV infections. It is a long-acting formulation of cabotegravir intended for use in preventing or treating HIV. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does Cabotegravir Formulation F target?

Cabotegravir Formulation F targets the HIV integrase enzyme, which is essential for viral replication. By inhibiting integrase, the drug blocks the integration of viral DNA into host cells, thereby reducing viral load. This mechanism is shared with other cabotegravir formulations, though the specific formulation is designed for extended release.

Who makes Cabotegravir Formulation F?

Cabotegravir Formulation F is developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. GSK is responsible for the clinical development and manufacturing of this investigational drug for HIV infections.

What phase is Cabotegravir Formulation F in?

Cabotegravir Formulation F is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.

What clinical trials is Cabotegravir Formulation F in?

Cabotegravir Formulation F has one completed clinical trial, NCT06033547, which investigated the pharmacokinetics, safety, and tolerability of two different long-acting cabotegravir formulations in healthy adult participants. The study enrolled 56 participants in the United States and was a controlled, open-label trial.

Is Cabotegravir Formulation F the same as other cabotegravir formulations?

Cabotegravir Formulation F is a specific long-acting formulation of cabotegravir, distinct from other formulations of the drug. The Phase 1 trial compared two different formulations of long-acting cabotegravir, with Formulation F being one of them. It is not the same as the approved cabotegravir products, which are used for HIV treatment and prevention.