Zidesamtinib
1 clinical trial1 recruiting6 countries
Neoplasms
- 6 countries
Substances
Discover drugs currently studied in clinical trials – page 172
4 127 substances in the catalogue9 767 linked trialsUpdated today
Top 10 most studied substances
Investigational medicinal products with the most registered trials right now.
No. 1 most studied
Pembrolizumab
NeoplasmsNervous System DiseasesImmune System Diseases
464Active trials · 16% of the top 10
- recruiting now
- 166
- countries
- 26
- open to children
- 2
Shares are of these ten substances' active trials together.
All substances
A substance is listed under the name its trial records use, which is often the generic one rather than a brand.
A–Z
4 127 substances
ZILEBESIRAN
1 clinical trial1 recruiting17 countries
Cardiovascular Diseases
- 17 countries
ZIMISLECEL
1 clinical trial1 recruiting5 countries
Nutritional and Metabolic Diseases
- 5 countries
ZINC
1 clinical trial1 recruiting1 country
Nutritional and Metabolic Diseases
- 1 country
Zinc Acetate Dihydrate
1 clinical trialnone recruiting1 country
Nervous System DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities
Zinc Acetate Dihydrate
Nervous System DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities
- 1 country
Zinc Acexamate
1 clinical trialnone recruiting1 country
Digestive System Diseases
Zinc Acexamate
Digestive System Diseases
- 1 country
ZINC GLUCONATE
1 clinical trialnone recruiting3 countries
Neoplasms
ZINC GLUCONATE
Neoplasms
- 3 countries
Zirconium (89Zr) Patritumab Deruxtecan
1 clinical trial1 recruiting1 country
Respiratory Tract DiseasesPathological Conditions, Signs and Symptoms
1 recruiting
Zirconium (89Zr) Patritumab Deruxtecan
Respiratory Tract DiseasesPathological Conditions, Signs and Symptoms
- 1 country
ZOLPIDEM TARTRATE
1 clinical trialnone recruiting1 country
Nervous System DiseasesTherapeuticsPhysiological processes
ZOLPIDEM TARTRATE
Nervous System DiseasesTherapeuticsPhysiological processes
- 1 country
Zopiclone
1 clinical trial1 recruiting1 country
Behavioral Disciplines and Activities
- 1 country
ZOREVUNERSEN SODIUM
1 clinical trialnone recruiting6 countries1 open to children
Nervous System Diseases
- 6 countries
ZUNIBERGENE ROCPARVOVEC
1 clinical trialnone recruiting9 countries
Eye Diseases
ZUNIBERGENE ROCPARVOVEC
Eye Diseases
- 9 countries
Albiglutide
no clinical trialsHormonal diseases
Albiglutide
Hormonal diseases
Azd5492
no clinical trialsHemic and Lymphatic Diseases
Azd5492
Hemic and Lymphatic Diseases
Bms-986458
no clinical trialsHemic and Lymphatic Diseases
Bms-986458
Hemic and Lymphatic Diseases
HUMANISED IGG4 MONOCLONAL ANTIBODY AGAINST C1Q
no clinical trialsImmune System DiseasesMusculoskeletal Diseases
HUMANISED IGG4 MONOCLONAL ANTIBODY AGAINST C1Q
Immune System DiseasesMusculoskeletal Diseases
Igg Against Serum Albumin Fused With Relaxin 2, Chain B (2-29) And Relaxin 2 (Chain A)
no clinical trialsCardiovascular Diseases
Igg Against Serum Albumin Fused With Relaxin 2, Chain B (2-29) And Relaxin 2 (Chain A)
Cardiovascular Diseases
Lixisenatide
no clinical trialsHormonal diseases
Lixisenatide
Hormonal diseases
Lorundrostat
no clinical trialsCardiovascular Diseases
Lorundrostat
Cardiovascular Diseases
Ly3871801
no clinical trialsMusculoskeletal Diseases
Ly3871801
Musculoskeletal Diseases
N-[4-Fluoro-5-[[2S,4S)-2-Methyl-4-[(5-Methyl-1,2,4-Oxadiazol-3-Yl)Methoxy]-1-Piperidinyl]Methyl]-2-Thiazolyl-Acetamide
no clinical trialsNervous System Diseases
N-[4-Fluoro-5-[[2S,4S)-2-Methyl-4-[(5-Methyl-1,2,4-Oxadiazol-3-Yl)Methoxy]-1-Piperidinyl]Methyl]-2-Thiazolyl-Acetamide
Nervous System Diseases
RIKKUNSHITO
no clinical trialsDigestive System DiseasesPathological Conditions, Signs and Symptoms
RIKKUNSHITO
Digestive System DiseasesPathological Conditions, Signs and Symptoms
Umeclidinium
no clinical trialsRespiratory Tract DiseasesEnvironment and Public Health
Umeclidinium
Respiratory Tract DiseasesEnvironment and Public Health
Investigational Medicinal Products (IMPs) in Clinical Trials
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.
What is an investigational medicinal product (IMP)?
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.
Can a placebo or a licensed therapy be an IMP?
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.
Types of investigational medicinal products
Novel IMPs
These are completely new molecular entities with no prior regulatory approval. They require comprehensive documentation covering preclinical toxicology, pharmacokinetics and manufacturing data.
Repurposed IMPs
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.
Modified IMPs
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.
The "Regulatory Green Light": approvals required before an IMP reaches trial sites
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".
IMPs across clinical trial phases
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.
Phase I: first-in-human trials
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.
Phase II: proof-of-concept trials
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.
Phase III: pivotal efficacy trials
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.
Who is responsible for the IMP?
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.
Glossary
- IMP (investigational medicinal product)
- A medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial.
- Placebo
- A product used as a reference in a clinical trial; it is also an IMP.
- Reference (comparator) product
- A product used as a reference or for control in a clinical trial.
- QP (Qualified Person)
- The person responsible for certifying and releasing IMP batches.
Frequently asked questions
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.