MedPath

Indinavir

Generic Name
Indinavir
Brand Names
Crixivan
Drug Type
Small Molecule
Chemical Formula
C36H47N5O4
CAS Number
150378-17-9
Unique Ingredient Identifier
9MG78X43ZT

Overview

A potent and specific HIV protease inhibitor that appears to have good oral bioavailability. [PubChem]

Indication

Indinavir is an antiretroviral drug for the treatment of HIV infection.

Associated Conditions

  • Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2010/02/11
Phase 2
Completed
Barbara Ensoli, MD, PhD
2008/03/18
Phase 2
UNKNOWN
Oncology Institute of Southern Switzerland
2006/08/10
Phase 2
Completed
2005/09/20
N/A
Completed
Harvard School of Public Health (HSPH)
2005/09/19
Phase 4
Completed
2005/09/12
Phase 3
Completed
French National Agency for Research on AIDS and Viral Hepatitis
2005/07/22
Not Applicable
Terminated
French National Agency for Research on AIDS and Viral Hepatitis
2005/07/19
Phase 2
Terminated
French National Agency for Research on AIDS and Viral Hepatitis
2003/07/11
Phase 2
Completed
2002/12/10
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
STAT Rx USA LLC
16590-064
ORAL
400 mg in 1 1
6/14/2012
Rebel Distributors Corp
21695-366
ORAL
400 mg in 1 1
11/4/2008
State of Florida DOH Central Pharmacy
53808-0661
ORAL
400 mg in 1 1
8/18/2010

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

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
No TGA approvals found for this drug.

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
CRIXIVAN 400 MG CAPSULAS DURAS
96024005
CÁPSULA DURA
Uso Hospitalario
Not Commercialized
CRIXIVAN 200 MG CAPSULAS DURAS
96024003
CÁPSULA DURA
Uso Hospitalario
Not Commercialized
CRIXIVAN 400 mg CAPSULAS DURAS
96024009
CÁPSULA DURA
Uso 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.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.