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VH4524184

Phase 2

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: May 8, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials6
Total Enrollment676
FDA Designations
No designations recorded
Clinical Trials (6)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07202546A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)PHASE2 RECRUITING 150 — — Feb 11, 2026Jul 24, 2028May 8, 2026113 United States, Argentina +11
NCT06214052VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living With HIV-1PHASE2 COMPLETED 22 — — Feb 7, 2024Jun 12, 2024Jun 29, 202517 United States, Argentina +3
NCT07066722A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy AdultsPHASE1 COMPLETED 126 — — Jul 7, 2025Dec 17, 2025Mar 9, 20262 United States
NCT06310551First Time in Human Study of Long Acting VH4524184 FormulationsPHASE1 RECRUITING 268 — — Mar 21, 2024Jan 21, 2028Apr 20, 20263 United States
NCT06310616A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female ParticipantsPHASE1 COMPLETED 26 — — Mar 6, 2024Aug 15, 2024Dec 10, 20241 United States
NCT05631704A Study to Investigate Safety, Tolerability, and Pharmacokinetics (PK) of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) ActivityPHASE1 COMPLETED 84 — — Dec 2, 2022Jul 27, 2023Dec 29, 20251 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants Achieving Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Suppression (<50 copies/millilitre) as per FDA Snapshot Methodology
At Month 12
Monotherapy: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA)
At Day 10

Plasma samples were collected for the quantitative analysis of plasma HIV-1 RNA. The maximum change from baseline was calculated by determining the largest change from baseline value across all assessment timepoints during the monotherapy period. This is identified by subtracting the lowest post-dose visit value up to Day 10 (inclusive) from the baseline value. The baseline was defined as the most recent pre-dose assessment with a valid, non-missing value, including measurements from any unscheduled visits.

Part 1: Maximum plasma concentration (Cmax) for VH4524184
Up to Day 18
Part 1: Area under the concentration-time curve from 0 to tau (AUC0-t) for VH4524184
Up to day 18
Part 1: Area under the concentration-time curve from 0 to infinity (AUC0-inf) for VH4524184
Up to day 18
Part 2: Cmax for VH4524184
At Day 1, Day 14, Day 19 and Day 22
Part 2: AUC0-t of VH4524184
At Day 1, Day 14, Day 19 and Day 22
Part 2: AUC0-inf of VH4524184
At Day 1, Day 14, Day 19 and Day 22
Part 2: Cmax for metformin
At Day 1 and Day 15
Part 2: AUC0-t for metformin
At Day 1 and Day 15
Part 2: Cmax for Digoxin
At Day 1 and Day 15
Part 2: AUC0-t for Digoxin
At Day 1 and Day 15
Percentage of participants reporting adverse events (AEs) and related AEs
From first study dose administration (Day 1) up to study end (Week 52 post last dose)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Related AE = AE assessed by the investigator as related to the study drug.

Percentage of participants with AEs by severity
From first dose administration (Day 1) up to study end (Week 52 post last dose)

Severity of AEs will be assessed using Division of AIDS Table for Grading the Severity of Adult Adverse Events (DAIDS). DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritis. The toxicity level is graded from Grade 1 (lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.

Percentage of participants discontinuing the treatment due to AEs
From first dose administration (Day 1) up to study end (Week 52 post last dose)
Change from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase parameters
From first dose administration (Day 1) up to study end (Week 52 post last dose)

The liver panel laboratory parameters are assessed after the administration of long-acting injectable (LAI) VH4524184.

Change from baseline in total bilirubin parameters
From first dose administration (Day 1) up to study end (Week 52 post last dose)

The liver panel laboratory parameters are assessed after the administration of LAI VH4524184.

Change from baseline in international normalized ratio (INR) parameters
From first dose administration (Day 1) up to study end (Week 52 post last dose)

The liver panel laboratory parameters are assessed after the administration of LAI VH4524184.

Maximum toxicity grade increase from baseline in ALT, AST and alkaline phosphatase
From first dose administration (Day 1) up to study end (Week 52 post last dose)
Maximum toxicity grade increase from baseline in total bilirubin
From first dose administration (Day 1) up to study end (Week 52 post last dose)
Maximum toxicity grade increase from baseline in INR
From first dose administration (Day 1) up to study end (Week 52 post last dose)
Percentage of participants reporting injection site reaction (ISR) AEs
From first dose administration (Day 1) up to study end (Week 52 post last dose)

Assessed ISRs are pain, tenderness, infections, erythema, swelling, induration, or nodules (granulomas or cysts). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, and Grade 4 = potentially life threatening.

Duration of injection site reaction AEs
From first dose administration (Day 1) up to study end (Week 52 post last dose)
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity time (AUC[0-inf]) of LAI VH4524184 following single dose administration
From first dose administration (Day 1) up to study end (Week 52 post last dose)
Area under the plasma drug concentration-time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-t]) of LAI VH4524184 following multiple dose administration
From first dose administration (Day 1) up to study end (Week 52 post last dose)
Maximum observed plasma drug concentration (Cmax) of LAI VH4524184 following single dose administration
From first dose administration (Day 1) up to study end (Week 52 post last dose)
Cmax of LAI VH4524184 following multiple dose administration
From first dose administration (Day 1) up to study end (Week 52 post last dose)
Time to maximum observed plasma drug concentration (Tmax) of LAI VH4524184 following single dose administration
From first dose administration (Day 1) up to study end (Week 52 post last dose)
Tmax of LAI VH4524184 following multiple dose administration
From first dose administration (Day 1) up to study end (Week 52 post last dose)
Apparent terminal half-life (t1/2) of LAI VH4524184 following single dose administration
From first dose administration (Day 1) up to study end (Week 52 post last dose)
t1/2 of LAI VH4524184 following multiple dose administration
From first dose administration (Day 1) up to study end (Week 52 post last dose)
Area under the concentration-time curve (AUC) from time zero (pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) of EE and NEA without coadministration with VH4524184
On Day 10

Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.

AUC0-Tau, ss of EE and NEA with coadministration with VH4524184
On Day 20

Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.

Maximum plasma concentration (Cmax) for EE and NEA without coadministration with VH4524184
On Day 10

Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.

Cmax for EE and NEA with coadministration with VH4524184
On Day 20

Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.

Part 1: Number of participants with serious adverse events (SAE) and non-serious adverse events (non-SAE)
Up to 4 weeks
Part 2: Number of participants with SAE and non-SAE
Up to 6.5 weeks
Part 3: Number of participants with SAE and non-SAE
Up to 6.5 weeks
Part 1: Number of participants with adverse events based on severity
Up to 4 weeks
Part 2: Number of participants with adverse events by severity
Up to 6.5 weeks
Part 3: Number of participants with adverse events based on severity
Up to 6.5 weeks
Part 1: Percentage of participants who discontinue treatment due to adverse events (AE)
Up to 4 weeks
Part 2: Percentage of participants who discontinue treatment due to AE
Up to 6.5 weeks
Part 3: Percentage of participants who discontinue treatment due to AE
Up to 6.5 weeks
Part 1: Change from Baseline in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline phosphatase (ALP) (International units per liter)
Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in AST, ALT and ALP (International units per liter)
Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in AST, ALT and ALP (International units per liter)
Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in International normalized ratio (INR) (Ratio)
Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in INR (Ratio)
Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in INR (Ratio)
Baseline (Day 1) and up to 6.5 weeks
Part 1: Number of participants with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR
Baseline (Day 1) and up to 4 weeks
Part 2: Number of participants with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR
Baseline (Day 1) and up to 6.5 weeks
Part 3: Number of participant with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR
Baseline (Day 1) and up to 6.5 weeks
Part 1: Area under the plasma-concentration time curve from zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) following dosing of VH4524184
Up to 4 weeks
Part 2: Area under the plasma concentration-time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tau]) following dosing of VH4524184
Up to 6.5 weeks
Part 1: Maximum observed plasma drug concentration (Cmax) following dosing of VH4524184
Up to 4 weeks
Part 2: Cmax following dosing of VH4524184
Up to 6.5 weeks
Part 1: Time to maximum observed plasma drug concentration (tmax) following dosing of VH4524184
Up to 4 weeks
Part 2: Tmax following dosing of VH4524184
Up to 6.5 weeks
Part 1: Apparent terminal half-life (t1/2) following dosing of VH4524184
Up to 4 weeks
Part 2: T1/2 following dosing of VH4524184
Up to 6.5 weeks
Secondary Endpoints
Percentage of Participants Maintaining Plasma HIV-1 RNA Suppression (<50 copies/mL) Based on Observed Laboratory Results
Day 1 to Month 24
Percentage of Participants Achieving Plasma HIV-1 RNA Suppression (<50 copies/ml) as per FDA Snapshot Methodology
Day 1 to Month 24
Change From Baseline in Cluster of Differentiation 4 (CD4+) T-cell Counts
Day 1 to Month 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VH4524184 Dose A+ FTC / TAFEXPERIMENTALParticipants receive a daily oral dose of VH4524184 Dose A (Low dose) in combination with a fixed dose containing FTC/TAF starting Day 1 until Month 12.
VH4524184 Dose B + FTC / TAFEXPERIMENTALParticipants receive a daily oral dose of VH4524184 Dose B (High dose) in combination with a fixed dose containing FTC / TAF beginning on Day 1 until the Month 12.
DTG + 3TCACTIVE_COMPARATORParticipants receive a daily oral dose of DTG and 3TC (fixed dose combination) from Day 1 through Month 24.
VH4524184 selected dose + FTC / TAFEXPERIMENTALParticipants receive a selected dose of VH4524184, combined with FTC/TAF, orally once daily from to Month 12 to Month 24.
VH4524184 Dose 1EXPERIMENTALParticipants received VH4524184, administered as Dose 1 (low dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label standard-of-care (SOC) antiretroviral therapy (ART), which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
VH4524184 Dose 2EXPERIMENTALParticipants received VH4524184, administered as Dose 2 (medium dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
VH4524184 Dose 3EXPERIMENTALParticipants received VH4524184, administered as Dose 3 (high dose) on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
PlaceboPLACEBO_COMPARATORParticipants received matching Placebo to the study intervention on Day 1, Day 4, and Day 7. On Day 10, participants began open-label SOC ART, which was selected by the investigator and locally sourced. Participants were monitored weekly until Day 38.
Part 1A_VH4524184 (Sequence 1)EXPERIMENTALParticipants will receive VH4524184 tablet(s) of Dose level 1 followed by Dose level 2 in fasted condition.
Part 1A_VH4524184 (Sequence 2)EXPERIMENTALParticipants will receive VH4524184 tablet(s) of Dose level 2 followed by Dose level 1 in fasted condition.
Part 1A_VH4524184 (Sequence 3)EXPERIMENTALParticipants will receive VH4524184 tablet(s) of Dose level 3 followed by Dose level 2 in fasted condition.
Part 1A_VH4524184 (Sequence 4)EXPERIMENTALParticipants will receive VH4524184 tablet(s) of Dose level 2 followed by Dose level 3 in fasted condition.
Part 1B_VH4524184 (Sequence 5)EXPERIMENTALParticipants will receive VH4524184 tablet of Dose level 2 in fasted condition and then followed by intake of a high fat meal.
Part 1B_VH4524184 Sequence 6)EXPERIMENTALParticipants will receive VH4524184 tablet of Dose level 2 following a high fat meal and then in fasted condition.
Part 1B_VH4524184 (Sequence 7)EXPERIMENTALParticipants will receive VH4524184 tablet of Dose level 3 in fasted condition and then followed by intake of a high fat meal.
Part 1B_VH4524184 (Sequence 8)EXPERIMENTALParticipants will receive VH4524184 tablet of Dose level 3 following a high fat meal and then in a fasted condition.
Part 2_Cohort 1EXPERIMENTALParticipants will receive VH4524184 tablet and Itraconazole.
Part 2_Cohort 2AEXPERIMENTALParticipants will receive VH4524184 and Rifabutin.
Part 2_Cohort 2BEXPERIMENTALParticipants will receive VH4524184 tablet and Phenytoin.
Part 2_ Cohort 3EXPERIMENTALParticipants will receive Metformin, Digoxin and VH4524184 tablets.
Formulation A SC GroupEXPERIMENTALParticipants receive a Formulation A starting dose of VH4524184 LAI subcutaneously (SC).
Formulation B SC GroupEXPERIMENTALParticipants receive a Formulation B starting dose of VH4524184 LAI subcutaneously (SC).
Formulation A IM GroupEXPERIMENTALParticipants receive a Formulation A starting dose of VH4524184 LAI intramuscularly (IM).
Formulation B IM GroupEXPERIMENTALParticipants receive a Formulation B starting dose of VH4524184 LAI intramuscularly (IM).
Multiple doses GroupEXPERIMENTALVH4524184 LAI formulations administered SC or IM as single doses that achieve adequate PK exposure targets, may be evaluated for safety and tolerability as multiple doses.
Loestrin + VH4524184EXPERIMENTALEligible participants entering a run-in period of 21 days (Days -28 through -8) will receive Loestrin (EE and NEA) to stabilize on the combined OCs containing EE and NEA to synchronize the menstrual cycles of multiple participants. Participants completing the run-in period will enter Treatment Period 1 and will be administered Loestrin once daily from Days 1 to 10. On Day 11, participants will enter Treatment Period 2 and will be administered Loestrin + VH4524184 once daily from Days 11 to 20.
Part 1: Cohort 1: Participants receiving VH4524184 DL1EXPERIMENTALEligible participants will receive VH4524184 Dose Level 1 (DL1) during Cohort 1 of Part 1 of the study.
Part 1: Cohort 1: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 DL1 during Cohort 1 of Part 1 of the study.
Part 1: Cohort 2: Participants receiving VH4524184 DL2EXPERIMENTALEligible participants will receive VH4524184 DL2 during Cohort 2 of Part 1 of the study.
Part 1: Cohort 2: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 DL2 during Cohort 2 of Part 1 of the study.
Part 1: Cohort 3: Participants receiving VH4524184 DL3EXPERIMENTALEligible participants will receive VH4524184 DL3 during Cohort 3 of Part 1 of the study.
Part 1: Cohort 3: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 DL3 during Cohort 3 of Part 1 of the study.
Part 1: Cohort 4: Participants receiving VH4524184 DL4EXPERIMENTALEligible participants will receive VH4524184 DL4 during Cohort 4 of Part 1 of the study.
Part 1: Cohort 4: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 DL4 during Cohort 4 of Part 1 of the study.
Part 1: Cohort 5: Participants receiving VH4524184 DL5EXPERIMENTALEligible participants will receive VH4524184 DL5 during Cohort 5 (optional) of Part 1 of the study.
Part 1: Cohort 5: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 DL5 during Cohort 5 (optional) of Part 1 of the study.
Part 1: Cohort 6: Participants receiving VH4524184 DL6EXPERIMENTALEligible participants will receive VH4524184 DL6 during Cohort 6 (optional) of Part 1 of the study.
Part 1: Cohort 6: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 DL6 during Cohort 6 (optional) of Part 1 of the study.
Part 2: Cohort 7: Participants receiving VH4524184 RL1EXPERIMENTALEligible participants will receive VH4524184 Repeat dose Level 1 (RL1) during Cohort 7 (Part 2) of the study.
Part 2: Cohort 7: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 RL1 during Cohort 7 (Part 2) of the study.
Part 2: Cohort 8: Participants receiving VH4524184 RL2EXPERIMENTALEligible participants will receive VH4524184 RL2 during Cohort 8 (Part 2) of the study. If Cohort 8 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of VH4524184
Part 2: Cohort 8: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 RL2 during Cohort 8 (Part 2) of the study. If Cohort 8 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of Placebo matching VH4524184.
Part 2: Cohort 9: Participants receiving VH4524184 RL3EXPERIMENTALEligible participants will receive VH4524184 RL3 during Cohort 9 (Part 2) (optional) of the study. If Cohort 9 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of VH4524184.
Part 2: Cohort 9: Participants receiving PlaceboPLACEBO_COMPARATOREligible participants will receive Placebo matching VH4524184 RL3 during Cohort 9 (Part 2) (optional) of the study. If Cohort 9 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of Placebo matching VH4524184.
Part 3: Cohort 10: VH4524184 Fasted/ VH4524184 FedEXPERIMENTALEligible participants will receive VH4524184 under fasted condition in Treatment Period 1 followed by VH4524184 under fed condition in Treatment Period 2 during Cohort 10 (Part 3) of the study. Treatment Periods will be separated by a washout period.
Interventions
NameTypeDescription
VH4524184DRUGOral tablet will be administered.
Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tabletsDRUGOral table will be administered.
Dolutegravir / Lamivudine (DTG/3TC)DRUGOral tablets will be administered.
Matching PlaceboDRUGVH4524184 Matching Placebo was administered as tablets orally at Day 1.
Antiretroviral therapyDRUGAntiretroviral therapy was administered as available and as per investigator's recommendation.
ItraconazoleDRUGItraconazole will be administered.
RifabutinDRUGRifabutin will be administered.
PhenytoinDRUGExtended phenytoin sodium will be administered.
MetforminDRUGMetformin will be administered.
DigoxinDRUGDigoxin will be administered.
Oral VH4524184DRUGVH4524184 to be taken orally.
VH4524184 Formulation A SCDRUGLow (\<1mL) starting dose of VH4524184 LAI Formulation A administered subcutaneously.
Placebo Formulation A SCDRUGStarting dose of Placebo Formulation A administered subcutaneously.
rHuPH20DRUGDose of rHuPH20 administered subcutaneously.
VH4524184 Formulation B SCDRUGStarting dose of VH4524184 LAI Formulation B administered subcutaneously.
Placebo Formulation B SCDRUGStarting dose of Placebo Formulation B administered subcutaneously.
VH4524184 Formulation A IMDRUGStarting dose VH4524184 LAI Formulation A administered intramuscularly.
Placebo Formulation A IMDRUGDose of Placebo Formulation A administered intramuscularly.
VH4524184 Formulation B IMDRUGStarting dose VH4524184 LAI Formulation B administered intramuscularly.
Placebo Formulation B IMDRUGDose of Placebo Formulation B administered intramuscularly.
LoestrinDRUGLoestrin will be administered.
MidazolamDRUGMidazolam will be administered in the highest dose cohort in Part 2 (Cohorts 8 or 9).
PlaceboDRUGPlacebo will be administered.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites113

Inclusion Criteria: 1. Participant must be at least 18 years of age (or older, if required for adults by local regulations) at the time of signing the informed consent. 2. Screening CD4+ T-cell count \>200 cells/microlitre (µL). 3. Documented HIV-1 infection and Screening plasma HIV-1 RNA of ≥1000 ...

Countries:United StatesArgentinaAustraliaBelgiumCanadaFranceGermanyItalyJapanPolandPortugalSpainTaiwan
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Competitive Landscape -Bacterial Infections 62 trials
CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15, ATM-AVI, BAT, Part A: ATM-AVI Single Dose, Cohorts 1-4, PG4 vaccine in Buffer 1 with low dose PA-001
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
GSK plc Sponsored ADRGSK4PHASE2MenABCWY vaccine, iNTS-GMMA Dose C, iNTS-GMMA Dose B, iNTS-GMMA Dose A, MenACWY
Zai Lab Ltd. Sponsored ADRZLAB1PHASE3Omadacycline, Moxifloxacin
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin, Vabomere
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar, Sinovac PCV24, high-dose Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline /kg, Sulbactam /kg -Durlobactam /kg
BiomX LtdPHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Moderna, Inc.MRNA1PHASE2mRNA-1982
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 — AIGIV, CYFENDUS, Collection of samples
Abbott LaboratoriesABT1NAUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06310551primaryCompletionDate: changed
LOWMay 26, 2026NCT07202546primaryCompletionDate: changed
LOWMay 24, 2026NCT06310551studyFirstPostDate: changed
LOWMay 24, 2026NCT07202546studyFirstPostDate: changed
MEDIUMMay 21, 2026NCT07066722TRIAL_REMOVED: changed
MEDIUMMay 21, 2026NCT07066722TRIAL_REMOVED: changed