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Estimates suggest that out of every 250 compounds that enter preclinical development, only 1 will receive FDA approval.
That's a 99.6% failure rate.
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Most people don't realize how tough it is to get a drug FDA-approved.
The drug development funnel shows exactly where compounds fall out.
Picture those 250 promising molecules starting the journey.
Here's the survival rate at each clinical phase: norstella.com/why-clini…
The math is kind of depressing.
💊 Phase I: 47% make it through (less than 1 in 2 survives safety testing)
💊 Phase II: 28% survive (the biggest hurdle where efficacy is proven or disproven)
💊 Phase III: 55% succeed (the final test before FDA submission)
Overall, 90% of clinical drug development fails, with Phase II serving as the toughest barrier where only 28% of compounds continue.
Only 6.7% of drugs entering Phase I will ultimately receive FDA approval.
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The costs compound at every level.
Each attempt requires 10-15 years from discovery to approval.
Scientists can dedicate entire careers to compounds that never make it to broad patient access or commercial success.
Financial investment is now around $2.6B per approved drug, with failed programs absorbing billions more in losses. greenfieldchemical.com/….
Hundreds of thousands of researchers persist in this work, fully aware of the overwhelming odds.
Behind these stats are real patients waiting for treatments. The rare compound that survives could be the breakthrough that changes everything for a disease community.
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These high failure rates aren't necessarily a sign of a broken system.
They reflect rigorous safety standards protecting patients from harmful drugs.
The question is whether the alternative (faster approvals with less evidence) would serve patients better. This is currently a tension at the FDA and is unlikely to go away.
Lower bars mean more approvals, but also more ineffective or unsafe drugs reaching the market. Higher bars mean fewer options, but greater confidence in what does get through.
You might be the patient waiting for a cure or the one protected from a dangerous compound.
What's the tradeoff you would take?
♻️ Repost to share how rare it is to get a drug approved.
🔔 Follow me for more content like this (Bryce Platt, PharmD)
