Phase 3
The penultimate stage of clinical drug development — large randomised trials testing efficacy and safety against existing standards of care.
Phase 3 trials test a drug candidate against either placebo or the existing standard of care in large patient populations (typically 1,000–10,000+ subjects) over months to years. Successful phase 3 trials produce the primary efficacy and safety dataset used in regulatory submissions to the FDA, EMA, MHRA, etc. Several research compounds in our catalogue — Retatrutide (TRIUMPH programme), Cagrilintide (REDEFINE programme) — are currently in phase 3. Approval typically follows 1–2 years after primary endpoint readout if the data is favourable.
- GlossaryPharmacokinetics
How the body absorbs, distributes, metabolises, and eliminates a compound — "what the body does to the drug."
- GlossaryPharmacodynamics
"What the drug does to the body" — the relationship between concentration and effect.
- GlossaryIV vs IM vs SC
Three injection routes — intravenous, intramuscular, subcutaneous — with different absorption profiles.