MARAVIROC
Maraviroc is an antiviral medication used to manage CCR5-tropic HIV-1 infection. It helps adult and pediatric patients who are at least two years old and weigh at least 10 kg when used alongside other antiretroviral therapies. This medication is specifically for those with the CCR5-tropic version of the virus and is not recommended for individuals with dual/mixed- or CXCR4-tropic HIV-1.
How MARAVIROC Works
Maraviroc works by acting as a CCR5 co-receptor antagonist. By targeting this specific co-receptor, the drug functions as an HIV-1 antiviral to help manage the infection.
Development Insights
Details
- Status
- None (Tentative Approval)
- First Approved
- 2022-02-07
- Routes
- ORAL
- Dosage Forms
- TABLET
MARAVIROC Approval History
What MARAVIROC Treats
1 indicationsMARAVIROC is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Human Immunodeficiency Virus Infection
MARAVIROC Boxed Warning
BOXED WARNING WARNING: HEPATOTOXICITY Hepatotoxicity has been reported with use of maraviroc tablets. Severe rash or evidence of a systemic allergic reaction (e.g., fever, eosinophilia, or elevated IgE) prior to the development of hepatotoxicity may occur. Patients with signs or symptoms of hepatitis or allergic reaction following use of maraviroc tablets should be evaluated immediately [see Warnings and Precautions ( 5.1 )]. WARNING: HEPATOTOXICITY See full prescribing information for complete ...
BOXED WARNING WARNING: HEPATOTOXICITY Hepatotoxicity has been reported with use of maraviroc tablets. Severe rash or evidence of a systemic allergic reaction (e.g., fever, eosinophilia, or elevated IgE) prior to the development of hepatotoxicity may occur. Patients with signs or symptoms of hepatitis or allergic reaction following use of maraviroc tablets should be evaluated immediately [see Warnings and Precautions ( 5.1 )]. WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. • Hepatotoxicity has been reported which may be preceded by severe rash or other features of a systemic allergic reaction (e.g., fever, eosinophilia, or elevated IgE). ( 5.1 ) • Immediately evaluate patients with signs or symptoms of hepatitis or allergic reaction. ( 5.1 )
MARAVIROC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MARAVIROC
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
64 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05470491 | 10000478 000478-C | Ph 1, Ph 2 | recruiting | Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ... |
| NCT00944541 145 MARIMUNO | ANRS 145 MARIMUNO 2009-011171-76 | Ph 2 | completed | Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration |
| NCT06853223 MARAVIROC | 25-43392 | Ph 2 | recruiting | This Study is Assessing the Safety and Efficacy of Immune Inhibition as a Treatment to Prevent Primary Graft Dysfunction |
| NCT07080567 MASTER | 2024-02359 215285 | Ph 2 | recruiting | Manipulating the Peri-Infarct Area Using Maraviroc to Enhance Motor Skills After Stroke |
| NCT06805656 | SPARC-11 | Ph 2 | not yet recruiting | Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Antiretrovirals |
| NCT01400412 results posted | ACTG A5303 1U01AI068636 | Ph 2 | completed | Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen |
| NCT04789616 CAMAROS | REB21-0258 | Ph 2 | recruiting | The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke |
| NCT02881762 MAVERIC results posted | HP-00070324 | Ph 4 | completed | Maraviroc Efficacy for Hepatitis C |
| NCT04435522 results posted | 1611471-1 | Ph 1 | completed | Maraviroc in Patients With Moderate and Severe COVID-19 |
| NCT02741323 results posted | HIVTR-CCR5 20730 | Ph 2 | completed | Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients |
| NCT02475915 | SEARCH 019 | Ph 1, Ph 2 | completed | Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection |
| NCT03274804 PICCASSO results posted | PICCASSO | Ph 1 | completed | Combined PD-1 and CCR5 Inhibition for the Treatment of Refractory Microsatellite Stable mCRC |
| NCT02778204 results posted | IMPAACT 2007 20734 | Ph 1 | completed | Evaluating the Safety and Pharmacokinetics of Maraviroc in HIV-1-Exposed Infants at Risk of Acquiring HIV-1 Infection |
| NCT01505114 results posted | HPTN 069/A5305 (NEXT Prep) 11789, HPTN 069/A5305 | Ph 2 | completed | Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women |
| NCT00537394 results posted | A5241 10395, ACTG A5241 | Ph 3 | completed | Optimizing Treatment for Treatment-Experienced, HIV-Infected People |
| NCT03129113 MAVMET | MAVMET | Ph 2, Ph 3 | completed | Adding MAraViroc &/or METformin for Hepatic Steatosis in People Living With HIV |
| NCT02159027 | H024 | Ph 2, Ph 3 | completed | Maraviroc and NeuroAIDS Pathogenesis |
| NCT04965662 Home PEPSE | JF006-3170 | Ph 4 | completed | The Role of Home Packs of HIV PEPSE in High Risk Individuals |
| NCT01276236 results posted | 11351 2860798 | Ph 2 | completed | Effects of Maraviroc (MVC) on HIV-related Kaposi's Sarcoma (KS) |
| NCT00925756 results posted | CCTG 590 | Ph 4 | completed | CCR5 Inhibitor Treatment Intensification on CD4+ T-cell Recovery |
| NCT00735072 results posted | GA9001DE | Ph 4 | completed | Maraviroc as an Immunomodulatory Drug for Antiretroviral-treated HIV Infected Patients Exhibiting Immunologic Failure |
| NCT01894776 RIFAMARA results posted | 2013 0080-01H | Ph 1 | completed | A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc |
| NCT02167451 results posted | 2014-1221 | Ph 1, Ph 2 | terminated | Maraviroc as GVHD Prophylaxis in Transplant Recipients |
| NCT00808002 | MARAVIBOOST | Ph 3 | completed | Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine |
| NCT00982878 results posted | 2008-008437-10 | Ph 1 | completed | The Maraviroc Central Nervous System (CNS) Study |
| NCT01348763 results posted | MRV_DRV_PK 2009-014924-42 | Ph 1 | completed | The Maraviroc Darunavir/Ritonavir Once Daily Pharmacokinetic Study |
| NCT00981773 SMASH | 1.0 18.6.2009 | Ph 4 | terminated | The St. Marys and The Mater Switch Study |
| NCT01449006 HANDmac results posted | 11/066 114560 | Ph 4 | completed | A Study of the Neurological Effects of Adding Maraviroc to HAART Regimen in Patients With HIV (HANDmac) |
| NCT02208037 results posted | BMTCTN1203 U01HL069294 | Ph 2 | completed | Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls (BMT CTN 1203) |
| NCT01327547 results posted | A4001098 2010-021994-35 | Ph 4 | completed | A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B |
| NCT02480894 | 206278 AI438-052 | Ph 1 | completed | A Open-label, Drug-Drug Interaction With Maraviroc (DDI) |
| NCT00719823 | A4001068 | Ph 3 | withdrawn | Maraviroc Compassionate Use |
| NCT01154673 results posted | 041009 | Ph 2, Ph 3 | completed | Effects of Intensive cART During Acute/Early HIV Infection |
| NCT01680536 CINAMMON | SSAT 046 | Ph 4 | completed | A Study to Assess Cerebrospinal Fluid INflammatory Markers After Addition of Maraviroc to MONotherapy Darunavir/Ritonavir - The CINAMMON Study |
| NCT00764465 results posted | COL112237 | Ph 2 | completed | An Interaction Study to Assess Drug Levels in Healthy Adult Subjects |
| NCT01384682 MARCH | 2011-01-MAR | Ph 4 | completed | Maraviroc Switch Collaborative Study |
| NCT01345630 MODERN results posted | A4001095 2010-021785-30 | Ph 3 | terminated | Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1 |
| NCT01749566 MVC-PREP | IRB00059752 KL2TR000455, ACTSIKL22012 | Ph 1 | completed | Exploring HIV Entry Blockade as a Pre-exposure Prophylaxis Strategy in Women |
| NCT01980329 | NA_00078492 | Ph 1 | completed | Polymorphic Effects of Cytochrome P450 3A5 on Pharmacokinetics of Maraviroc and Its Metabolites |
| NCT01719627 | MARAVIPREX | Ph 1 | completed | First Study to Evaluate the Capacity of Maraviroc Drug to Protect Against HIV Infection in Samples of Rectal Mucosa From Healthy Volunteers |
| NCT00795444 | ERRADVIH-01 Eudra CT 2007-003995-21 | Ph 2 | completed | Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1 |
| NCT01866267 SUDS | SUDS_GSK117335 | Ph 4 | completed | Switching Undetectables to Selzentry |
| NCT00993148 MIDAS results posted | MIDAS | Ph 2 | completed | Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1 |
| NCT00844519 results posted | HIVCADRFA | Ph 3 | completed | Effect of Maraviroc on Endothelial Function in HIV-Infected Patients |
| NCT02039323 | 13-3940 | Ph 1 | completed | A Feasibility Study to Assess Tenofovir and Maraviroc Protection Against HIV-1 in Cervical and Vaginal Explants |
| NCT01133210 | 10-0533 | Ph 1 | completed | Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I) |
| NCT00875368 MIRS | 08-283 | Ph 4 | completed | Maraviroc Immune Recovery Study |
| NCT00884858 | HLS/MVC01/2008 | Ph 4 | completed | Maraviroc in Immunological Non-Responder (INR) HIV-1-infected Subjects |
| NCT00853840 results posted | A4001074 | Ph 4 | completed | Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc |
| NCT00666705 results posted | A4001082 | Ph 4 | completed | A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects |
Showing 50 of 64 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MARAVIROC FDA Label Details
Indications & Usage
MARAVIROC is indicated for the treatment of Human Immunodeficiency Virus Infection.
BOXED WARNING WARNING: HEPATOTOXICITY Hepatotoxicity has been reported with use of maraviroc tablets. Severe rash or evidence of a systemic allergic reaction (e.g., fever, eosinophilia, or elevated IgE) prior to the development of hepatotoxicity may occur. Patients with signs or symptoms of hepatiti...
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SELZENTRY
Full clinical data, patents, trials, and competitive landscape for maraviroc.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment