Raltegravir

Overview

Raltegravir is an antiretroviral drug produced by Merck & Co., used to treat HIV infection. It received approval by the U.S. Food and Drug Administration (FDA) on 12 October 2007, the first of a new class of HIV drugs, the integrase inhibitors, to receive such approval.

Indication

For the treatment of HIV-1 infection in conjunction with other antiretrovirals.

Associated Conditions

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)	2023/03/02	NCT05751031	N/A	Recruiting	Fondazione Penta UK
Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers	2022/12/13	NCT05648201	Phase 4	Recruiting	Radboud University Medical Center
The Influence of Concurrent Oral Calcium Carbonate Supplementation on Steady State Pharmacokinetics of Oral Raltegravir.	2020/02/06	NCT04258475	Phase 4	Recruiting	Ottawa Hospital Research Institute
Combination Antiretroviral Therapy (cART) for PBC	2019/05/17	NCT03954327	Phase 2	Completed	University of Alberta
Neuropsyquiatric Evolution After Introduction of Raltegravir QD in Substitution of Dolutegravir: NEAR QD Study	2018/11/06	NCT03732625	Phase 4	UNKNOWN	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851)	2018/09/12	NCT03667547	Phase 4	Completed	Merck Sharp & Dohme LLC
A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs	2018/05/25	NCT03537404	Phase 1	Completed	R-Pharm
Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir	2017/12/15	NCT03374358	Phase 4	Completed	Helsinki University Central Hospital
Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen	2017/11/06	NCT03333083	Phase 3	Terminated	Judit Pich
Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM	2017/10/17	NCT03311945	Phase 3	Completed	Judit Pich

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ISENTRESS	Direct_Rx	61919-706	ORAL	400 mg in 1 1	1/12/2021
ISENTRESS	RedPharm Drug, Inc.	67296-1235	ORAL	400 mg in 1 1	2/5/2023
ISENTRESS	Physicians Total Care, Inc.	54868-0117	ORAL	400 mg in 1 1	2/7/2012
ISENTRESS	NuCare Pharmaceuticals,Inc.	68071-2113	ORAL	400 mg in 1 1	7/17/2023
ISENTRESS	RPK Pharmaceuticals, Inc.	53002-1686	ORAL	400 mg in 1 1	5/27/2022
ISENTRESS	A-S Medication Solutions	50090-1085	ORAL	400 mg in 1 1	11/15/2023
ISENTRESS	Dispensing Solutions, Inc.	66336-214	ORAL	400 mg in 1 1	6/14/2013
ISENTRESS	REMEDYREPACK INC.	70518-1621	ORAL	400 mg in 1 1	6/23/2025
ISENTRESS	Merck Sharp & Dohme LLC	0006-0477	ORAL	100 mg in 1 1	11/15/2023
ISENTRESS	Merck Sharp & Dohme LLC	0006-3603	ORAL	100 mg in 1 1	11/15/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Isentress	Merck Sharp & Dohme B.V.,Waarderweg 39,2031 BN Haarlem,The Netherlands	Authorised	12/19/2007

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Isentress® Chewable Tablet 25 mg	Patheon Pharmaceuticals Inc., Merck Sharp & Dohme BV	SIN14522P	TABLET, CHEWABLE	25 mg	3/7/2014
ISENTRESS® 400MG TABLET	MSD International GmbH (Ballydine), MSD INTERNATIONAL GMBH (SINGAPORE BRANCH), PT. Organon Pharma Indonesia Tbk (Primary and Secondary Packager)	SIN13568P	TABLET, FILM COATED	400 mg	11/5/2008
ISENTRESS-G TABLET 400MG	MSD INTERNATIONAL GMBH (SINGAPORE BRANCH), PT. Organon Pharma Indonesia Tbk (Primary and Secondary Packager)	SIN13936P	TABLET, FILM COATED	400 mg	3/24/2011
Isentress® Chewable Tablet 100 mg	Patheon Pharmaceuticals Inc., Merck Sharp & Dohme BV	SIN14523P	TABLET, CHEWABLE	100 mg	3/7/2014
ISENTRESS HD FILM-COATED TABLET 600MG	MSD INTERNATIONAL GMBH (SINGAPORE BRANCH), PT. Organon Pharma Indonesia Tbk (Primary and Secondary Packager)	SIN15935P	TABLET, FILM COATED	600mg	4/27/2020

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ISENTRESS raltegravir 400 mg tablet bottle	140238	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	1/30/2008
ISENTRESS HD raltegravir 600 mg tablet bottle	280294	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	8/23/2017

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ISENTRESS 100 MG COMPRIMIDOS MASTICABLES	Merck Sharp & Dohme B.V.	107436004	COMPRIMIDO MASTICABLE	Diagnóstico Hospitalario	Commercialized
ISENTRESS 25 MG COMPRIMIDOS MASTICABLES	Merck Sharp & Dohme B.V.	107436003	COMPRIMIDO MASTICABLE	Diagnóstico Hospitalario	Commercialized
ISENTRESS 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Merck Sharp & Dohme B.V.	07436001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
ISENTRESS 600 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Merck Sharp & Dohme B.V.	107436006	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	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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