Preclinical
Company
During preclinical testing, drugs undergo basic laboratory investigation and other nonclinical testing to assess activity and safety, prior to human testing. This step typically takes 1 to 2 years.
Phase 1
Company
Phase 1 trials are the first step in transforming laboratory data into clinical care. They determine the safety and appropriate dosage of the drug for humans. Phase 1 trials are typically conducted in healthy volunteers first, and may also include some patients. They vary in size but typically involve 20-80 subjects. This step typically takes 1 to 2 years.
Phase 2
Company
Phase 2 trials begin if Phase 1 trials don’t reveal unacceptable toxicity. The emphasis in Phase 2 is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. Typically, the number of subjects in Phase 2 trials ranges from a few dozen to about 300.
Phase 3
Company
Phase 3 trials begin if evidence of effectiveness is shown in Phase 2. These trials gather more information about safety and effectiveness, studying different populations and different dosages and using the drug in combination with other drugs. Phase 3 trials enroll several hundred to about 3,000 people.
Market
Company
After successful completion of Phase 3 or pivotal testing, a company will submit the results of all of the studies to the FDA in a New Drug Application (NDA). Once the FDA grants a company approval of an NDA, the company can market the drug (medication) to the public. This step typically takes 2 to 4 years.
HIV Infection
Lexiva/Telzir
GlaxoSmithKline
Company
Company
Company
Company
Company
Company
Lexiva was co-discovered by Vertex and GlaxoSmithKline and first marketed in 2003.
HCV Infection
Telaprevir (VX-950)
Janssen, Mitsubishi
Company
Company
Company
Company
Company
Company
Telaprevir is an investigational hepatitis C protease inhibitor in Phase 3 clinical development.
HCV Infection
VX-500
Company
Company
Company
VX-500 is a second-generation HCV protease inhibitor. Vertex has initiated dosing in a Phase 1a clinical trial of VX-500.
HCV Infection
VX-813
Company
Company
VX-813 is a second-generation HCV protease inhibitor currently in preclinical development.
Bacterial Infection
VX-883
Company
Company
Company
VX-883 is a novel investigational antibiotic.
Cystic Fibrosis
VX-770
CF Foundation
Company
Company
Company
Company
Company
VX-770 is a novel oral agent for CF. Phase 2 began in May 2007.
Cystic Fibrosis
VX-809
CF Foundation
Company
Company
VX-809 is a novel correrctor compound for CF. Vertex has initiated dosing in a Phase 1a trial for VX-809 in healthy volunteers.
Cancer
MK-0457 (VX- 680)
Merck
Company
Company
Company
Enrollment in Phase 2 trials of MK-0457 has been suspended pending a full analysis of all safety and efficacy data. Please see press release dated 11/20/07 for additional information.
Cancer
VX-689
Merck
Company
VX-689 is a novel Aurora kinase inhibitor expected to enter a Phase 1 trial in early 2008 for the treatment of cancer.
Cancer
AVN-944 (VX-944)
Avalon
Company
Company
Company
AVN-944 is a investigational compound being developed by Avalon for the treatment of cancer.
Rheumatoid Arthritis
VX-702
Company
Company
Company
Company
Company
VX-702 is an investigational oral cytokine inhibitor in Phase 2 for RA.
Inflammatory Diseases
VX-509
Company
Company
VX-509 is a novel JAK3 inhibitor designed for the treatment of immune-mediated inflammatory diseases currently in preclinical development.
Development Pipeline
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