Glossary · Regulation
Trial phases (phase 1, 2, 3)
In short
Before a medicine is authorized, it goes through clinical trials in three successive phases. Phase 1 tests tolerability in a few people, phase 2 looks for an effect and a suitable dose, phase 3 confirms benefit and safety in many.
Phase 1 trials often involve a few dozen healthy people, phase 2 up to a few hundred patients, phase 3 hundreds to thousands over months to years. Before that come laboratory and animal studies; after authorization, phase 4 follows as observation in everyday use.
Many candidates fail along the way, often in phase 2 or 3, because the effect does not materialize or side effects appear. A substance “in phase 2” is therefore far from being a future medicine.
In the biohacking scene, some substances are sold that never got beyond phase 1. Then there are data on tolerability in a few people, but none on efficacy.
Phase 3 confirms — everything before it is a hint.
Where this comes up in the fact checks
- Retatrutide – After the phase 2 trial, TRIUMPH-1 has appeared as the first peer-reviewed phase 3 trial; the substance is not yet authorized anywhere.
- Andarine – Never developed beyond phase 1.
- CJC-1295 with DAC – The only phase 2 trial was stopped in 2006 after a death of unclear connection.
Sources
Related terms: Marketing authorization (EMA, FDA, BfArM) · Randomized controlled trial (RCT) · Primary endpoint
Information only, not medical advice. The BK-Score is a subjective assessment according to disclosed rules – not a scientific evaluation. Scoring rules