A Surge in Investigational New Drug Activity

Once a biological product or pharmaceutical shows promise and general safety in laboratory animal studies, companies or researchers (sponsors) can apply for Investigational New Drug (IND) status. IND status allows the sponsor to conduct clinical trials to further investigate the efficacy and safety of the pharmaceutical or biologic.

To receive IND designation, the sponsor must submit an IND application to FDA that includes:

1. Preclinical data demonstrating the product is “reasonably safe” for testing in humans
2. Manufacturing information to demonstrate the sponsor is capable of producing and supplying consistent batches of the compound
3. Detailed protocols for the proposed clinical studies

You can find the full set of rules and regulations for IND Applications in the Code of Federal Regulations Title 21 CFR Part 312

IND Receipts and Active IND’s from 2014-2023 ¶

Since the drugs are pre-approval, the FDA does not make details about the drugs available in a central database, and instead provides annual aggregate statistics.

The IND summary statistics include the number of IND’s granted per year and the number of Active INDs, where Active IND’s are IND’s that are undergoing trials or other processes with FDA. The IND summary reports distinguishes between two types: “CDER Drug and Non-Biosimilar Biologic IND Receipts” and “CDER Biosimilar Biologic IND Receipts”. Each type is divided into two IND categories: “Commercial” and “Research” (non-commercial) IND’s¹.

One interesting thing about this figure is the jump in IND receipts and Active IND’s in 2020. There were no significant changes to the regulations around IND Applications during this time², but there was a worldwide public health crisis with COVID 19. My initial hypothesis is that COVID-19 spurred significant activity in new drug and biologic development as the world raced for vaccines or treatments.

To test this, we will look at clinical trial investigations during a similar time period in a future post.