Key result
Among 12 cardiovascular drug candidates discontinued in Phase I-III trials from 2016 to 2018, six were dropped for lack of clinical efficacy and six for strategic or unspecified reasons.
Why the study?
Only one compound reaches the market out of approximately 10,000 tested, making it useful to analyze discontinued cardiovascular drugs to improve future R&D strategies.
Reviewing discontinued cardiovascular drugs highlights that lack of clinical efficacy and absence of selection biomarkers are major reasons for failure in Phase I-III trials.
Persistent efficacy gaps in cardiovascular candidates leave open whether biomarker-guided selection can reduce Phase I-III discontinuations.
Cardiovascular drug research and development (R&D) has been in active state and continuously attracts attention from the pharmaceutical industry. However, only one individual drug can eventually reach the market from about the 10,000 compounds tested. It would be useful to learn from these failures when developing better strategies for the future. Discontinued drugs were identified from a search performed by Thomson Reuters Integrity. Additional information was sought through PubMed, ClinicalTrials.gov, and pharmaceutical companies search. Twelve compounds discontinued for cardiovascular disease treatment after reaching Phase I-III clinical trials from 2016 to 2018 are detailed in this manuscript, and the reasons for these failures are reported. Of these, six candidates (MDCO-216, TRV027, ubenimex, sodium nitrite, losmapimod, and bococizumab) were dropped for lack of clinical efficacy, the other six for strategic or unspecified reasons. In total, three candidates were discontinued in Phase I trials, six in Phase II, and three in Phase III. It was reported that the success rate of drug R&D utilizing selection biomarkers is higher. Four candidate developments (OPC-108459, ONO-4232, GSK-2798745, and TAK-536TCH) were run without biomarkers, which could be used as surrogate endpoints in the 12 cardiovascular drugs discontinued from 2016 to 2018. This review will be useful for those involved in the field of drug discovery and development, and for those interested in the treatment of cardiovascular disease.
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Li et al. (2019) conducted a review in Cardiovascular disease. Cardiovascular drug candidates was evaluated on Reasons for drug discontinuation. Among 12 cardiovascular drug candidates discontinued in Phase I-III trials from 2016 to 2018, six were dropped for lack of clinical efficacy and six for strategic or unspecified reasons.
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