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Investigational medicinal products with the most registered trials right now.
No. 1 most studied
Shares are of these ten substances' active trials together.
A substance is listed under the name its trial records use, which is often the generic one rather than a brand.
4 127 substances
An investigational medicinal product is any substance being tested in a clinical trial. It may be entirely new, or a medicine already approved for a different condition that researchers are now studying somewhere else.
A substance appearing here does not mean it is approved, effective or available as a treatment. It means at least one registered trial in Europe is studying it – which is exactly the question a trial is asked to answer.
Put simply, an investigational medicinal product is the drug or biologic being tested in a clinical trial. This also includes placebos and comparator products used for control.
The official definition comes from Regulation (EU) No 536/2014, which defines an IMP as "a medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial".
The ICH E6(R2) Good Clinical Practice guidelines describe an IMP in a similar way, as "a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial".
In practice, an IMP can be a completely new compound, an existing therapy or a placebo. The category covers everything from new gene therapies to established therapies being evaluated for new indications or patient populations.
Yes. Whether a product is an IMP does not depend on whether the therapy is new, but on the role it plays in the clinical trial. Medicinal products that already have a marketing authorisation are IMPs too when they are used as the test product, reference product or placebo in a clinical trial.
This applies, for example, when a licensed therapy is tested for an unapproved indication, when an approved drug is used in a different formulation or packaging, when an existing treatment is evaluated in a new patient population, when approved therapies are combined in novel configurations, or when a product serves as a reference or placebo in a comparative trial.
These are completely new molecular entities with no prior regulatory approval. They require comprehensive documentation covering preclinical toxicology, pharmacokinetics and manufacturing data.
These are existing therapies being investigated for new therapeutic applications. Although some safety data may already exist, additional trials are typically required for the new indication.
These are approved therapies with changes to their dosage form or strength, route of administration or target patient population, or therapies combined with other active substances.
Before investigational medicinal products are released to clinical trial sites, the trial sponsor is responsible for ensuring that three things are in place: certification by a Qualified Person (QP), approval from the regulatory authority, and approval from the ethics committee. This requirement is known as the "Regulatory Green Light".
Trial descriptions usually state which phase a trial is in. Each phase has different objectives, and the requirements for the IMP change as development progresses.
The main objectives are safety assessment, determining the dosage range and preliminary pharmacokinetic evaluation. The IMP comes from limited manufacturing batches, safety monitoring is rigorous, and flexible dosing formulations are used to allow dose escalation.
The main objectives are evaluating efficacy, determining optimal dosing and expanding the safety assessment. At this stage, consistent manufacturing processes are required, reference products are used for comparison, and formulations are designed to be patient-friendly.
The main objectives are confirming efficacy on a large scale, comprehensive safety evaluation and preparing the regulatory submission. Manufacturing focuses on process validation, development of commercial manufacturing methods, establishing a global supply chain and compliance with regulations across multiple jurisdictions.
The trial sponsor holds ultimate responsibility for IMP quality. The sponsor must ensure appropriate manufacturing, storage, transport and site suitability throughout the clinical trial. The Qualified Person (QP) is responsible for batch release.
An IMP is any pharmaceutical preparation used in a clinical trial, including new drugs, existing therapies tested for new uses, or products in different formulations than their approved form. Regular medicinal products have a marketing authorisation for specific approved uses.
Yes. A therapy with a marketing authorisation is an IMP when it is used as the test product, reference product or placebo in a clinical trial.
Yes. Under Regulation (EU) No 536/2014, a product used as a reference, including as a placebo, in a clinical trial is an investigational medicinal product.
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