Almost Nine Years, and Not Getting Faster

| Intended Reader

• Heads of R&D, chief medical officers and biotech executive teams
  
  

| Key Takeaways

• It still takes almost nine years (median 104 months) from first-in-human to FDA approval, and that hasn't improved since 2020.
• The fastest quarter of programs reach approval about two years ahead of the median.
• Speed doesn't cost quality: only 4% of the fastest programs were rejected on their first application, against 20% of the rest.

What every FDA novel approval since 2020 tells us about how long drug development takes, and why the median is the wrong number to aim for.

Drug development gives people something money can’t buy: time with the people they love. Yet it takes a median of 104 months, almost nine years, to take a new drug from the first patient dosed to FDA approval, and every one of those months is time patients spend waiting. That figure comes from Scimitar’s benchmark of every FDA novel approval since January 2020: 356 drugs, each traced back through its trial registrations, company disclosures and FDA records.

And it isn’t getting faster. Despite new modalities, AI-assisted trial design, decentralized trials and expanded use of expedited pathways, the median has stayed within a narrow band for seven years.

The median hasn’t moved

There is no meaningful trend across these years. A drug approved this year took about as long to develop as one approved in 2020.

The spread is the real story

The median hides an enormous range. Some programs reach approval in under five years; others take more than fourteen.

• The fastest quarter of programs reached approval in 79 months or less, about 6.6 years.
• The slowest quarter took 144 months or more, 12 years.
• Four in ten programs took more than ten years.

The gap between the median and the top quartile is about two years. The gap between the fastest and slowest quarters is more than five. These programs ran under the same FDA, in the same era, to the same standards of evidence.

Where the fastest programs gain their time

We followed the fastest quarter through each stage of development and compared them with everyone else. The difference doesn’t come from one place.

Three things stand out:

1. Phase 1 is not where the race is won. The fastest programs ran Phase 1 no faster than anyone else.
2. The biggest difference comes before pivotal. Fast programs reach their pivotal trial about 33 months sooner, mostly through Phase 2 and the gaps around it.
3. They are faster at every later stage too. The pivotal trial, the filing and the review are each shorter. Speed compounds.

Over the coming weeks we’ll take each of these stages in turn.

Fast doesn’t mean cutting corners

Speed only matters if quality and rigor hold, and the data suggests they do. Only 4% of the fastest quarter of programs received a complete response letter, FDA’s refusal to approve on the first application, compared with 20% of all other programs.

Fast programs did carry somewhat more post-approval study requirements: a median of 3 FDA-required studies against 2. That reflects accelerated pathways for serious diseases, where FDA approves on earlier evidence and asks for confirmation after launch. The rigor is still there; it comes in a different order.

Two years sooner for patients

Two years is not just a schedule problem. For the patients a new medicine is meant for, it is two more years of living with a disease without it, and for some, time they don’t have. It is also two years of development spend and, as we’ll show later in the series, years of protected revenue lost at the other end. But the first cost is the one that matters most.

Questions to ask about your own programs

1. Where would your last three approvals or late-stage programs sit on this curve?
2. For each program in your pipeline, what would reaching patients a year sooner mean for the people waiting for it?
3. Do you measure development time from the same starting point, first patient dosed, across your portfolio?
4. Which stage took longest against the benchmark, and do you know why?
5. How much of your timeline was spent running trials, and how much waiting between them?

What’s next in the series

Next week: the two years nobody manages, the white space between studies when no trial is running. After that we look at overlapping phases, Phase 2, pivotal trial design, small biotechs, therapeutic area, FDA designations, deals and the patent clock, before closing with what the top quartile does differently.

How Scimitar helps

The gap between the median and the top quartile isn’t luck. It’s built stage by stage, from decisions about design, sequencing and hand-offs that can be planned well before the data arrives. Closing it means medicines reach patients sooner. That’s the work Scimitar does with sponsors.

For 20 years, Scimitar has helped sponsors get medicines to patients faster, from first-in-human through submission, with the quality and rigor patients deserve. This benchmark of every FDA novel approval since 2020 draws on that experience. If you’d like to see where your program sits against the benchmark, start a conversation with our team.

About the data: Scimitar benchmark of 356 FDA novel approvals (CDER new molecular entities and new therapeutic biologics, plus CBER cell and gene therapies; diagnostic agents excluded), January 2020 to October 31, 2026. First-in-human is the date the first participant was dosed in the first clinical trial of the molecule, anywhere in the world. Total time is measured to the FDA approval date; 305 drugs have both dates. Sources: FDA approval letters and review documents, ClinicalTrials.gov and other trial registries, company disclosures and SEC filings.

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