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Published on: May 25, 2020
Discontinued cardiovascular drugs in 2013 and 2014
Hong-ping Zhao1, Bing-ren Xiang
1China Pharmaceutical University, Center for Instrumental Analysis, Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education , Nanjing, Jiangsu 210009 , China hpzhaojstar@126.com.
Insights
Ten cardiovascular drugs were discontinued between 2013-2014, primarily due to safety and efficacy issues. This analysis reviews these failures to inform future drug development, particularly for cardiovascular diseases (CVDs).
Area of Science:
- Pharmaceutical Science
- Cardiology
- Drug Development
Background:
- Cardiovascular diseases (CVDs) represent a leading global cause of mortality.
- High attrition rates in drug development necessitate analysis of past failures.
- Understanding reasons for drug discontinuation is crucial for pharmaceutical innovation.
Purpose of the Study:
- To analyze cardiovascular drugs discontinued between 2013 and 2014.
- To identify common reasons for early-stage drug development failures.
- To provide insights for improving future cardiovascular drug discovery.
Main Methods:
- Focused on 10 cardiovascular drug candidates.
- Included drugs discontinued after animal studies or Phase I-II clinical trials.
- Examined data from January 1, 2013, to December 31, 2014.
Main Results:
- Ten cardiovascular drugs were discontinued during the study period.
- Two candidates failed in Phase I, and eight in Phase II clinical trials.
- Lack of efficacy and safety concerns were the primary reasons for discontinuation.
Conclusions:
- The rate of cardiovascular drug development terminations showed a change during 2013-2014.
- Analysis revealed efficacy and safety as key factors in early-stage failures.
- Notable discontinuations include an orphan drug (RTA-402) and a PCSK9 inhibitor (RG-7652).
Introduction:
Cardiovascular diseases (CVDs) are the number one cause of death globally. The dramatically high rate of cardiovascular morbidity and mortality has attracted wide concern and great attention within the pharmaceutical industry. However, ∼ 10,000 compounds are tested for every one drug that reaches the market. For this reason, it is helpful to recapitulate previous failures and learn from these experiences.
Areas Covered:
This paper focuses on the 10 cardiovascular drugs discontinued after reaching animal studies or Phase I - II clinical trials between 1 January 2013 and 31 December 2014.
Expert Opinion:
The trend of increasing numbers of cardiovascular drug development terminations seen in recent years has changed. Only 10 cardiovascular drugs were discontinued after reaching animal studies or Phase I - II clinical trials between 2013 and 2014. Only two candidates were discontinued in the Phase I clinical evaluation, and eight were discontinued during Phase II development. Most discontinuations were attributed to lack of efficacy and safety. One orphan drug (RTA-402) appeared in the list of discontinued cardiovascular drugs. The most eye-catching one of the 10 discontinued drugs is RG-7652, a monoclonal antibody against PCSK9, which is predicted as the next statin.
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