Discontinued cardiovascular drugs in 2015

ABSTRACT

Introduction: About 10,000 compounds will be tested for an individual drug to eventually reach the market. It might be helpful recapitulating previous failures and identifying the main factors of the disappointments.

Areas covered: In this review, the author(s) detailed the 7 cardiovascular compounds discontinued after reaching animal studies or Phase I—III clinical trials during 2015. Meanwhile, the reasons for these discontinuations were reported. Among these drugs, most discontinuations (6 drugs) were attributed to lack of efficacy. In general, failures due to lack of efficacy and safety demonstrate the need for the development of more predictive animal models. However, recent related studies showed that the absence of toxicity in animals provided little or virtually no evidential weight that adverse drug reactions would also be absent in humans. In this case, microdosing and collaborating more closely with biotech companies may be the better choices to improve the success ratio.

Expert opinion: Future researches may benefit from the seven developments and investigators conducting similar studies may learn from these failures.

KEYWORDS:

• TAK-272
• PF-05285401
• CI-201
• ciclosporin
• beraprost sodium
• icatibant acetate
• evacetrapib

Article highlights

• The number of cardiovascular drug development terminations in recent years has been reduced.

• 7 cardiovascular drug candidates were discontinued after reaching animal studies or Phase I – III clinical trials in 2015.

• A broad range of mechanisms of action is represented in terminated cardiovascular candidates.

• After two CETP inhibitors, torcetrapib and dalcetrapib were discontinued, Evacetrapib, the third CETP inhibitor was discontinued due to the same reason.

• Six sevenths of discontinuations were attributed to efficacy.

• Microdosing and collaborating more closely with biotech companies were suggested to improve the success ratio.

This box summarizes key points contained in the article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This paper has received no funding.