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At a Glance
- Spain authorized 962 clinical trials in 2025 maintaining its leadership position in the European Union.
- Early phase studies rose from 156 in 2015 to 244 in 2025 representing 25% of total authorizations.
- Oncology dominated with nearly 40% of trials followed by immune system diseases and nervous disorders.
Spain leads the EU in clinical trials, according to 2025 approval data that show that nearly 1,000 studies were greenlit in the country last year
Theanalysis(in Spanish) by the Madrid-headquartered Spanish Agency of Medicines and Medical Products (AEMPS) revealed that 962 trials were approved in 2025, continuing the growth trend seen over the past decade
The numbers reflect Spain’s key role in the EU trials sector, according to the AEMPS analysts, who wrote, “Our country is a leader in key areas such as research into drugs for treating cancer, rare diseases, advanced therapies, and innovative medicines—fields that require a high level of specialization and are a priority for public health.”
Spain also managed to attract a significant number of multinational clinical trials, with 758 of the approved studies being carried out at research sites in multiple countries
The authors wrote, “These studies are crucial because they allow for the recruitment of a sufficient number of patients in different countries to obtain robust results and accelerate the development of innovative treatments, thus consolidating Spain’s role as a preferred partner for the sponsors of these trials.”
Therapeutic areas
The AEMPS analysis also looked at the types of studies being conducted in Spain and found that oncology is a major area of activity
Nearly 40% of the authorized studies focused on cancers. Immune system diseases were the next biggest category (10.5%), followed by disorders of the nervous system (6.9%), and then cardiovascular conditions (6.2%)
The analysis also showed that 22.5% were focused on rare diseases
Early phase studies
The number of early phase studies also increased in 2025, continuing the trend seen over the past decade
In 2015, 156 Phase I and Phase I/II trials were authorized. Ten years later, this number had risen to 244, representing 25% of the total authorized
According to the authors, the increase “demonstrates the interest in bringing new developments to Spain. Prioritizing the evaluation of early-phase trials strengthens Spain’s position in drug innovation.”
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