Blog
nuevo farmaco

How long does it take to develop a new drug?

Share

There are currently countless drugs on the market to choose from, but do we really know what the drug development process involves? 

The process of developing a new drug usually takes a total of 10 to 15 years on average. The process can be divided into three main phases: 

  1. Drug discovery, the first phase in which candidate compounds are selected based on their pharmacological properties. 
  2. Preclinical development, a phase in which a wide range of studies are performed in the laboratory. Characteristics of the drug, such as toxicity, effects, formulation, among others, are tested. 
  3. Clinical development, the phase of testing of the selected drug’s effectiveness, side effects, and potential risks in healthy volunteers and patients. 

These phases are not necessarily performed in the strict order shown here but generally have some overlap. 

Image extracted from Elsevier, Stages of Development of a New Drug 

 Drug Discovery 

 Typically, drug development begins with the identification of a “target.” The target is generally a protein associated with a human disease that the new drug is intended to impact. Once located, a “high-performance selection” process is performed, in which the molecules that bind to this target to impact or modify it are identified. These become the first candidates for the new drug. 

The next step is to optimize candidate molecules to make them more specific and bind better to our target. Once optimized, a first characterization is performed of how these molecules act in the body, studying drug absorption, distribution, metabolism and elimination, among others. 

Preclinical development 

 This phase is one of the most important, since a large amount of data is collected on the candidate molecules. Characteristics such as toxicity, effective dose and safety are tested in animal models. 

 In addition, the optimal drug formulation is studied, as well as the feasibility of large-scale production, using computer models. 

 In this stage, we determine the so-called no observable adverse effect level (NOAEL) of the drug, which will be used to determine a safe dose range in subsequent clinical trials with patients. 

Clinical development 

 Clinical development is what we know as the clinical trial, the phase in which the efficacy and safety of the drug is studied in patients. This process is often the longest and most expensive of the whole development process. Clinical development is divided into 3 phases to evaluate different aspects: 

  • Phase I includes the first clinical trials in a small group of volunteers to study the safety profile of the drug, including the safe dose range. These studies also determine its absorption, distribution, metabolism, and excretion, as well as its duration of action. 
  • In Phase II, the drug is tested in a larger group of patients with the disease studied in order to evaluate its safety, efficacy and to establish the appropriate therapeutic dose. 
  • Phase III includes large-scale clinical trials with several hundred to thousands of patients with the aim of establishing the safety and efficacy of the drug in the specific indications for regulatory approval. It is also possible to compare the new drug with a standard treatment and thus assess the risk-benefit ratio of the new drug.  

After completing Phase III, the medicinal product enters the regulatory approval process, in which all data is reviewed in a comprehensive manner. Once approved, the drug is ready to be marketed. 

Phase IV clinical trials are conducted once the drug is already on the market, and their objective is to determine and monitor the long-term effects of the drug.  

Sources

Rang and Dale. Farmacología 

Novartis 

We unite people and science because sharing is moving forward.

Share

Leave a Reply

Your email address will not be published. Required fields are marked *

You may also be interested...

participar en un ensayo clinico
Clinical trials

Benefits of enrolling in a clinical trial

It is always up to the patient to decide whether to enroll in a clinical trial. Patients always have the …

linfoma de hodgkin
Awareness

Hodgkin Lymphoma

We have been hearing a lot about this type of tumor lately, particularly since its diagnosis in public figures like …

matchtrial france
Press room

MatchTrial® lands in France

With the internationalization of MatchTrial® services, Science4Tech has taken a big stride ahead. The app, which uses a combination of …

Press room

“The future of the healthtech industrylies in putting technology at the service of people and their needs”

Science4Tech appoints Cristina Fernández, PhD in Chemometrics, as Chief Product & Innovation Officer. Cristina chemist postgraduate with passion for new …

Do you want access to oncology clinical trials?

Download the App on iOS or Android now