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Atlas/Small molecules/Baxfendy/First dose

Baxfendy: how was the first human dose set?

baxdrostat · Aldosterone synthase (CYP11B2)
Check my plan vs. these
First-in-human starting dose
Not stated in public reviews
Why it's blank

The public FDA and EMA reviews of Baxfendy don't say how the first human dose was chosen. That rationale is in the IND, which is confidential, so it is missing for most approved products.

How it's usually set for small molecules outside oncology

Find the highest dose with no adverse effects (NOAEL) in each animal species, convert it to a human equivalent dose, usually by body surface area, pick the most appropriate species, then divide by a safety factor (default 10) to get the maximum recommended starting dose.

“In general, one should consider using a safety factor of at least 10. The MRSD should be obtained by dividing the HED by the safety factor.”
✓ VerifiedFDA 2005: Estimating the Maximum Safe Starting Dose in Initial Clinical…, p. 7Source ↗
This product's starting point

NOAEL / key findings: Dehydration; adrenal zona glomerulosa hypertrophy and renal juxtaglomerular hyperplasia in monkeys, pharmacology-related (FDA pharmacology/toxicology review, p. 20)

Full method, every step sourced →

NOAEL / key findings
Dehydration; adrenal zona glomerulosa hypertrophy and renal juxtaglomerular hyperplasia in monkeys, pharmacology-related
“Frequently observed findings were primarily related to the primary pharmacology of baxdrostat, including dehydration (rats and monkeys) and microscopic findings in adrenal glands (zona glomerulosa hypertrophy) and kidneys (juxtaglomerular cell hyperplasia) in monkeys.”
✓ VerifiedFDA pharmacology/toxicology review, p. 20Source ↗

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Summary across all 211 small molecules →