Investigational New Drug (IND) is a term predominantly used in the pharmaceutical industry. It refers to a new drug that is under investigation in clinical trials but has not yet received approval from regulatory authorities for general use. The IND application must be submitted to, and approved by, the Food and Drug Administration (FDA) in the U.S. before the drug enters the trial phase involving human participants.
The phonetic pronunciation of “Investigational New Drug (IND)” is:Investigational: /ɪnˌvɛstɪˈɡeɪʃənl/New: /njuː/Drug: /drʌɡ/IND: /aɪɛnn’diː/
- An Investigational New Drug (IND) application consists of data gathered from animal experimentations and toxicity studies, manufacturing and processing details, clinical protocols and investigator data. This information is critical in assessing whether it’s secure to proceed to human testing.
- An IND is a part of the drug development process in the United States and is essential for drugs that have not yet been approved by the Food and Drug Administration (FDA). The application is submitted by the company or research group responsible for the drug’s development and must be approved before clinical trials involving humans can begin.
- The IND’s approbation is determined solely on safety grounds – it doesn’t have to show efficacy or actual potential benefit. The drug can continue to the clinical trial phase once the IND is approved, which typically includes three stages of testing on different populations and eventually mass production if the drug is shown to be safe and effective.
The Investigational New Drug (IND) application is crucial in the pharmaceutical industry as it signifies a pivotal step in the drug development process. The IND is filed with the U.S. Food and Drug Administration (FDA) to obtain approval for testing new medications on humans in clinical trials. This application is essential as it provides the FDA with information related to the drug’s safety, manufacturing, and the proposed plan for testing in humans. Therefore, it heavily influences whether the drug’s development can progress, thus dictating its future within the marketplace. An IND’s significance lies in its role in protecting the safety of trial participants and ensuring that the pharmaceutical companies follow rigorous standards to contribute to the safe introduction of new therapeutics into the market.
The purpose of an Investigational New Drug (IND) involves creating a pathway for a new pharmaceutical or treatment procedure to ensure safety before being tested in human clinical trials. The IND is a central part of drug development and is intended to protect patients who are partaking in the trials. It’s the regulatory vehicle through which sponsors legally file with the Food and Drug Administration (FDA) to progress from non-clinical tests on animals and the laboratory to tests on humans during clinical trials.The application for IND contains data compiled from laboratory experimentation detailing the pharmacological profile of the drug, its structure, the composition, and how it works in the body. Further more, the application outlines the design for the first few stages of the human clinical trial. The IND is essential for sustaining the progression of new treatments. In essence, the IND application bridges the gap between the discovery of a potential new drug and its marketing, paving the way for clinical investigations that comply with ethical standards and regulatory requirements.
1. Pfizer and BioNTech’s Investigational New Drug application (IND) for a COVID-19 Vaccine: Pfizer and BioNTech submitted an IND application to the U.S. Food and Drug Administration (FDA) in May 2020 for their vaccine candidate (BNT162) against SARS-CoV-2. Today, this vaccine, known as Pfizer-BioNTech COVID-19 Vaccine, is being widely used globally to combat the COVID-19 pandemic.2. Geron Corporation’s Imetelstat: Geron, a late-stage clinical biopharmaceutical company, filed an IND in 2009 for imetelstat, an investigational drug for the treatment of various types of myeloid malignancies. Imetelstat is now being examined in multiple clinical trials under collaborative development and license agreement with Janssen Biotech, Inc.3. Genentech’s Avastin: Genentech filed an IND for their drug, Avastin, to investigate its efficacy in the treatment of various forms of cancer. Avastin has now been approved by FDA for treating certain types of colon, lung, kidney, and brain cancers.
Frequently Asked Questions(FAQ)
What is an Investigational New Drug (IND)?
An Investigational New Drug (IND) is a term used for a new pharmaceutical drug or biologic that the U.S. Food and Drug Administration (FDA) allows to be used in clinical trials, but is not yet approved for commercial marketing.
Why is an IND application necessary?
An IND application is necessary since it signifies the transitioning of drug testing from laboratory animals into humans. It is essential for ensuring the safety of the patients involved in clinical trials.
What does an IND application include?
An IND application typically includes information on the drug’s composition and manufacturing, pharmacological and toxicological data, detailed protocol for conducting the proposed clinical trial, and the researcher’s qualifications to conduct the trial.
Who submits an IND application?
The IND application is usually submitted by the pharmaceutical company or the biologic sponsor who is developing the drug.
What happens after the IND application is submitted?
Following submission, the FDA reviews the application to determine the safety and viability of launching clinical trials. If the FDA approves, the drug can be shipped across state lines for clinical studies. If it disapproves, the applicant is provided with reasons for this decision and suggestions for potential modifications.
What are the phases of clinical trials following the IND approval?
A clinical trial usually occurs in three phases following IND approval: Phase 1: Tests the drug on a small number of healthy volunteers to study safety and side effects. Phase 2: The drug is tested on more participants to evaluate effectiveness, side effects, and appropriate dosage. Phase 3: The drug is given to even larger groups of people to confirm effectiveness, monitor side effects, and compare it to commonly used treatments.
What is the difference between commercial IND and research IND?
A commercial IND is filed by the company intending to market the drug, while a research IND is filed by researchers conducting independent studies, often at academic institutions.
What happens once all clinical trial phases are completed?
Once all clinical trials phases are completed successfully, and the drug is found to be safe and effective, the company can file a New Drug Application (NDA) or Biologics License Application (BLA) to the FDA for approval.
How long does the IND application review process take?
The FDA is typically required to respond to an IND application within 30 days.
Related Finance Terms
- Phase 1 Clinical Trial
- Food and Drug Administration (FDA)
- New Drug Application (NDA)
- Biologic License Application (BLA)
- Pharmaceutical Research
Sources for More Information
- U.S. Food & Drug Administration
- Clinical Trials Arena
- National Center for Biotechnology Information
- National Cancer Institute