Maraviroc

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Investigating Measurable PRO Acuity Trial (IMPACT) is a Multi-Center Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Maraviroc and Atorvastatin to Improve Neurocognitive and Physical Function of Subjects With Long COVID-19/Post-Acute Sequelae of COVID-19 (PASC).	2025/05/15	NCT06974084	Phase 2	Not yet recruiting	HealthBio, Inc.
This Study is Assessing the Safety and Efficacy of Immune Inhibition as a Treatment to Prevent Primary Graft Dysfunction	2025/02/28	NCT06853223	Phase 2	Not yet recruiting	University of California, San Francisco
Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Antiretrovirals	2025/02/03	NCT06805656	Not Applicable	Not yet recruiting	Federal University of São Paulo
Antiviral Clinical Trial for Long Covid-19	2024/07/19	NCT06511063	Phase 2	Recruiting	Icahn School of Medicine at Mount Sinai
Safety of Maraviroc for Post-stroke Depression	2023/07/06	NCT05932550	Phase 2	Completed	Tel-Aviv Sourasky Medical Center
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 ...	2022/07/22	NCT05470491	Phase 1	Recruiting	National Cancer Institute (NCI)
Safety and Efficacy of Maraviroc in Post-stroke Cognitive Impairment	2021/07/19	NCT04966429	Phase 2	UNKNOWN	Tel-Aviv Sourasky Medical Center
The Role of Home Packs of HIV PEPSE in High Risk Individuals	2021/07/16	NCT04965662	Phase 4	Completed	Guy's and St Thomas' NHS Foundation Trust
The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke	2021/03/09	NCT04789616	Phase 2	Recruiting	University of Calgary
Trial to Evaluate the Safety and Efficacy of Maraviroc in Patients Hospitalized for Coronavirus Disease 2019 (COVID-19)	2021/01/14	NCT04710199	Phase 2	Completed	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
SELZENTRY	ViiV Healthcare Company	49702-223	ORAL	150 mg in 1 1	9/26/2022
SELZENTRY	ViiV Healthcare Company	49702-233	ORAL	25 mg in 1 1	9/26/2022
Maraviroc	XLCare Pharmaceuticals Inc.	72865-231	ORAL	150 mg in 1 1	7/12/2023
Maraviroc	i3 Pharmaceuticals, LLC	72319-025	ORAL	300 mg in 1 1	8/18/2023
Maraviroc	Navinta LLC	68475-007	ORAL	300 mg in 1 1	6/23/2025
Maraviroc	Camber Pharmaceuticals, Inc.	31722-579	ORAL	150 mg in 1 1	1/27/2022
SELZENTRY	ViiV Healthcare Company	49702-235	ORAL	75 mg in 1 1	9/26/2022
Maraviroc	Navinta LLC	68475-008	ORAL	150 mg in 1 1	6/23/2025
SELZENTRY	Physicians Total Care, Inc.	54868-5809	ORAL	300 mg in 1 1	5/23/2012
Maraviroc	XLCare Pharmaceuticals Inc.	72865-232	ORAL	300 mg in 1 1	7/12/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Celsentri	ViiV Healthcare B.V.,Van Asch van Wijckstraat 55 H,3811 LP Amersfoort,The Netherlands	Authorised	9/18/2007

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Celsentri Film-Coated Tablet 150mg	Pfizer Manufacturing Deutschland GmbH	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	葛兰素史克	N/A	N/A	7/17/2008
CELSENTRI TAB 150MG	N/A	葛兰素史克	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	Waymade Australia Pty Limited	Medicine	A	9/25/2024
MARAVIROC WAYMADE maraviroc 150 mg film coated tablet blister pack	422790	Waymade Australia Pty Limited	Medicine	A	9/25/2024
CELSENTRI maraviroc 150 mg tablets blister packs	137329	ViiV Healthcare Pty Ltd	Medicine	A	2/4/2008
CELSENTRI maraviroc 300 mg tablets blister packs	137331	ViiV Healthcare Pty Ltd	Medicine	A	2/4/2008

Related News

HealthBio Launches FDA Fast-Track Trial for Long COVID Treatment Using Maraviroc-Atorvastatin Combination

5 months ago

• HealthBio initiates Phase III clinical trial testing a novel combination of Selzentry (maraviroc) and Lipitor (atorvastatin) for Long COVID treatment, involving 252 patients in a randomized, double-blind study. • The company's approach targets vascular inflammation through CCR5 pathway modulation, supported by preliminary data showing promising results in over 12,000 treated patients. • With $10M initial funding and FDA Fast-Track designation, the trial aims to address a condition affecting up to 23 million Americans and causing an estimated $3.7 trillion economic impact.

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