The Significance of Investigational New Drugs

Life to most people is a beautiful and precious phenomenon. However, we all understand that living comes with numerous drawbacks. One of these challenges is the prevalence of various hard-to-treat diseases. Nonetheless, science and modern medicine play a critical role in facilitating our health maintenance as we go about our lives. How exactly, do new innovative medicines come to market? One way is that of what is known as an Investigational New Drug (IND) process.

The Early Phases of the Investigational New Drug Proces

Let us discuss the Investigational New Drug process as it functions in the United States. In the United States a firm or company is required to apply, and be granted a marketing application before a new drug can be transported across state lines1. While developing a new drug, a company will want to send this drug out all over the country to various clinical investigators for the purpose of study and research. However, in order to do so, the company must obtain a legal exemption from the marketing application that is required by law to transport a drug across state lines1. Hence, the Investigational New Drug designation, enables a company to bypass the marketing application requirement and transport a new drug across state lines legally for research and use in human beings.

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Furthermore, in the early stages of Drug Development a manufacturer usually has a few fundamental concerns. One of the main challenges is establishing as to whether or not the drug in question will be safe to use in human beings, as well as whether or not the drug has demonstrated promising commercial results. When a manufacturer identifies a drug that meets these two criteria, then the process of performing yet more research and collecting more data1 begins. The purpose of collecting more data is to ensure the safety of the human subjects.

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The Food and Drug Administration (FDA) comes into consideration at the point when the manufacturer is certain that human beings will not be subject to harm and the new drug is ready to be tested on humans. Moreover, the legal status of the developmental drug changes at this time as well. FDA considers three types of Investigational New Drugs (IND):

  • Investigator Investigational New Drug– This occurs when an investigator submits a research Investigational New Drug application. The investigator performs the research and administration of the new drug with the purpose of analyzing a drug that has yet to be approved, or attempting to realize new applications for an already approved drug1.
  • Emergency use Investigational New Drug– This allows the FDA to approve the use of a drug that is currently being researched, and bypasses the standard Investigational New Drug requirements as well as processes1. A great example of this situation is in the advent of COVID-19. When there was no vaccine for COVID-19 many pharmaceutical companies applied for emergency use INDs with the hope of getting the COVID-19 situation under control. The medications were able to be fast tracked due to the emergency use IND.
  • Treatment Investigational New Drug – This occurs when manufactures identify potential new drugs that exhibit great promise, especially with potential new drugs that are capable of treating serious or life threatening illnesses1.

Furthermore, there are typically two Investigational New Drug categories. The first category is that of which an IND is intended for commercial use. These are drugs usually developed by pharmaceutical companies with the intention of selling them on the free market. The second category are INDs that are developed for the purpose of research (non-commercial) use. These tend to be INDs that are typically being studied in academia.

Disease and sickness will always exist as long as human beings live on this planet. Luckily, we have science and modern medicine to help us combat these challenges. Furthermore, the Investigational New Drug process plays a critical role in this matter as it aims to ensure that new drugs that come to market are applicable and safe to use on humans.

The IND files include data from different experimental models to ensure the safety and the efficacy of the new drugs, together with clinical trial data in humans.

Zebrafish data have been contributing to the various files of New Investigational Drugs. This is because Zebrafish have a uniquely similar genetic structure to that of human beings They share more than seventy percent of genes with humans, and more than 82% of the genes involved in human diseases are maintained in zebrafish. For this reason, together with its small size, transparency, easiness to grow and use for massive screenings, among other characteristics, zebrafish have become very important to medical research. The use of the Zebrafish model can help in a more time and cost-efficient way as opposed to other traditional methods thus significantly reducing the time that is required in typical IND studies. 

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  1. S. Food & Drug Administration, ‘Investigational New Drug (IND) Application’ date accessed on 8/19/2022:







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