■ExplainerExplainer12 Jan 20262 min read
Not every stage move is the same size
A step from phase 2 to phase 3 is the hardest gate in drug development. A step from filed to approved is usually the easiest. Here is how we weigh them.
No stage change: explainer Mixed or neutral: news, but no net change in prospects.
The readThe board shows position; this piece explains distance. A molecule in phase 3 is not three fifths of the way to approval in any probabilistic sense.
Five stages and unequal gaps
On the board, every molecule sits in one of five columns: phase 1, phase 2, phase 3, filed and approved. The columns are evenly spaced, but the odds of crossing each gap are not.
A widely cited industry analysis of development programmes from 2011 to 2020 put the chances of moving on roughly like this:
| Gap | Rough chance of crossing |
|---|---|
| Phase 1 to phase 2 | about 1 in 2 |
| Phase 2 to phase 3 | under 1 in 3 |
| Phase 3 to filing | a bit over 1 in 2 |
| Filing to approval | about 9 in 10 |
Multiplied together, only around 8 percent of drugs entering phase 1 reached approval. Rates vary by disease area; metabolic and endocrine drugs, which make up much of this board, have tended to do somewhat better than average.
What that means for reading our moves
- A phase 2 to phase 3 move is the biggest step on the board, even though it looks like one column.
- A filed to approved move is expected most of the time; a rejection at that point is the surprise.
- A deal does not move a molecule, but it often changes the odds that the next trial gets run quickly and well.
Why peptides are a special case
Peptides tend to hit their intended targets cleanly, which helps in early phases. Their hard problems come later: manufacturing at scale, devices for self-injection, and oral delivery. Two of the moves on the board, the delay for palopegteriparatide and the oral PCSK9 result for enlicitide, are really stories about those problems.
Position is a fact. Odds are an estimate. We try never to mix the two in a headline.
Our method page, where these rules are kept up to date.
Primary sourcePeptide Exchange newsroom; BIO, Informa and QLS clinical development success rates 2011-2020
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