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2024 & 2025 FDA Phase 1 Submissions


FDA Phase 1 Studies
FDA Phase 1 Studies

One of the benefits of taking a 6-Month Sabbatical is the ability to research a topic pretty quickly. For the past 4.5 years, my teams and I have chased down early pharma development -- working to secure a collaboration on the sponsor's molecule under development.


As such, we were always keenly interested in Phase 1 submissions. Were they growing? Where were they being done?


A quick check of www.clintrials.gov for the 1st Q of 2025 compared to the 1st Q of 2024 yields some interesting results. Thanks to ChatGPT for the formatting:


Some other observations:

  • The vast majority of the "unknown locations" in 2025 are from Universities and ex-US entities.

  • By far, the US is the largest producer of phase 1 multi-site trials (ie - multiple locations listed)

  • The vast majority, but not all, of the multi-site studies were all conducted in one country, not across multiple ones.

  • By memory alone, the 2nd most popular site for ex-US trials is Australia, followed by Korea.

  • Given the many Chinese sponsor companies behind these phase 1 trials and the many studies that are not FIH oral studies, I wonder what truly the addressable market is for US/EU centered CDMOs trying to sign on these Phase 1 studies?

  • I think in this hyper-competitive environment, it is critical to get the Phase 1 where you can as a CDMO player, and not 'hope' it comes to you when it 'scales'. It just begs the question: How much is there to be 'gotten'?


AV




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