Overview
Maraviroc (brand-named Selzentry, or Celsentri outside the U.S.) is a chemokine receptor antagonist drug developed by the drug company Pfizer that is designed to act against HIV by interfering with the interaction between HIV and CCR5. It was originally labelled as UK-427857 during development but was assigned the Maraviroc name as it entered trials. It was approved for use by the FDA in August, 2007.
Indication
Maraviroc is indicated in combination with other antiretroviral agents for the treatment of CCR5-tropic HIV-1 infection in adults and pediatric patients weighing at least 2kg. It is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1.
Associated Conditions
- CCR5-tropic Human Immunodeficiency Virus Type 1 (HIV-1) Infection
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Research Report
Maraviroc (DB04835): A Comprehensive Monograph on a First-in-Class CCR5 Antagonist from HIV-1 Therapy to Broad-Spectrum Immunomodulation
1.0 Executive Summary
Maraviroc (DrugBank ID: DB04835) represents a significant milestone in the history of antiretroviral therapy (ART). As the first orally bioavailable small molecule antagonist of the C-C chemokine receptor type 5 (CCR5), its approval marked the introduction of a new class of HIV medications in over a decade.[1] Developed by Pfizer and marketed under the brand names Selzentry and Celsentri, Maraviroc introduced a novel mechanism of action that fundamentally differs from preceding antiretroviral agents. Instead of inhibiting viral enzymes once HIV has already infected a host cell, Maraviroc functions as an entry inhibitor, blocking the virus at the cell surface before infection can occur.[3]
The drug's primary clinical indication is for the treatment of human immunodeficiency virus type 1 (HIV-1) infection, but its use is highly specific. It is effective only against viral strains that utilize the CCR5 co-receptor for cellular entry, known as CCR5-tropic (or R5) virus.[1] This mechanistic specificity necessitates pre-treatment viral tropism testing, positioning Maraviroc as an early example of personalized medicine in infectious disease management.[6] Its clinical utility is most established in treatment-experienced patients with multidrug-resistant HIV, for whom it provides a new therapeutic option with no cross-resistance to other drug classes.[2]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/23 | Not Applicable | Recruiting | Emmanuel Carrera | ||
2025/05/15 | Phase 2 | Not yet recruiting | HealthBio, Inc. | ||
2025/02/28 | Phase 2 | Not yet recruiting | |||
2025/02/03 | Not Applicable | Not yet recruiting | Federal University of São Paulo | ||
2024/07/19 | Phase 2 | Recruiting | |||
2023/07/06 | Phase 2 | Completed | |||
2022/07/22 | Phase 1 | Recruiting | |||
2021/07/19 | Phase 2 | UNKNOWN | |||
2021/07/16 | Phase 4 | Completed | |||
2021/03/09 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
ViiV Healthcare Company | 49702-223 | ORAL | 150 mg in 1 1 | 9/26/2022 | |
ViiV Healthcare Company | 49702-233 | ORAL | 25 mg in 1 1 | 9/26/2022 | |
XLCare Pharmaceuticals Inc. | 72865-231 | ORAL | 150 mg in 1 1 | 7/12/2023 | |
i3 Pharmaceuticals, LLC | 72319-025 | ORAL | 300 mg in 1 1 | 8/18/2023 | |
Navinta LLC | 68475-007 | ORAL | 300 mg in 1 1 | 6/23/2025 | |
Camber Pharmaceuticals, Inc. | 31722-579 | ORAL | 150 mg in 1 1 | 1/27/2022 | |
ViiV Healthcare Company | 49702-235 | ORAL | 75 mg in 1 1 | 9/26/2022 | |
Navinta LLC | 68475-008 | ORAL | 150 mg in 1 1 | 6/23/2025 | |
Physicians Total Care, Inc. | 54868-5809 | ORAL | 300 mg in 1 1 | 5/23/2012 | |
XLCare Pharmaceuticals Inc. | 72865-232 | ORAL | 300 mg in 1 1 | 7/12/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 9/18/2007 | ||
Authorised | 9/18/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
Celsentri Film-Coated Tablet 150mg | SIN13640P | TABLET, FILM COATED | 150mg | 4/30/2009 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
CELSENTRI TAB 300MG | N/A | N/A | N/A | 7/17/2008 | |
CELSENTRI TAB 150MG | N/A | N/A | N/A | 7/17/2008 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
MARAVIROC WAYMADE maraviroc 300 mg film coated tablet blister pack | 422791 | Medicine | A | 9/25/2024 | |
MARAVIROC WAYMADE maraviroc 150 mg film coated tablet blister pack | 422790 | Medicine | A | 9/25/2024 | |
CELSENTRI maraviroc 150 mg tablets blister packs | 137329 | Medicine | A | 2/4/2008 | |
CELSENTRI maraviroc 300 mg tablets blister packs | 137331 | Medicine | A | 2/4/2008 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
CELSENTRI 150 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 07418003 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
CELSENTRI 300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 07418008 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
MARAVIROC TARBIS 150 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tarbis Farma S.L. | 89504 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
MARAVIROC TARBIS 300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tarbis Farma S.L. | 89505 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
MARAVIROC WAYMADE 300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Waymade B.V. | 89845 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Not Commercialized |
MARAVIROC WAYMADE 150 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Waymade B.V. | 89844 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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