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Atlas/Small molecules/Ztalmy/First dose

Ztalmy: how was the first human dose set?

ganaxolone · GABA-A receptor (positive modulator)
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 Ztalmy 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: Dose-related reversible sedation in rats and dogs; little other target-organ or systemic toxicity (FDA pharmacology/toxicology review, p. 112)

Full method, every step sourced →

NOAEL / key findings
Dose-related reversible sedation in rats and dogs; little other target-organ or systemic toxicity
“The most common effect observed in the pivotal repeat-dose toxicology studies in adult rats and dogs was dose-related, reversible sedation, an expected pharmacological action of a positive modulator of GABAA receptors. Otherwise, there was little evidence of target organ or systemic toxicity in either species.”
✓ VerifiedFDA pharmacology/toxicology review, p. 112Source ↗

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Livmarli

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Lybalvi

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Lynavoy

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Myqorzo

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Nereus

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Nexletol

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Nextstellis

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Nourianz

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Nubeqa

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Nurtec ODT

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Nuzolvence

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Ogsiveo

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Ohtuvayre

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Ojemda

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Ojjaara

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Olinvyk

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Not stated in public reviews

Omlonti

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Not stated in public reviews

Ongentys

opicapone · COMT
Not stated in public reviews

Orgovyx

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Not stated in public reviews

Orladeyo

berotralstat · Plasma kallikrein
Not stated in public reviews

Orlynvah

sulopenem etzadroxil and probenecid · Penicillin-binding proteins
Not stated in public reviews

Orserdu

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Not stated in public reviews

Orzeyful

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Oxbryta

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Piqray

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Pizensy

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Not stated in public reviews

Ponvory

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Not stated in public reviews

Pretomanid

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Not stated in public reviews

Pyrukynd

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Not stated in public reviews

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Not stated in public reviews

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Not stated in public reviews

Qulipta

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Not stated in public reviews

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Not stated in public reviews

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Not stated in public reviews

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Not stated in public reviews

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Sohonos

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Not stated in public reviews

Sotyktu

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Not stated in public reviews

Sunlenca

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Not stated in public reviews

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Not stated in public reviews

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Not stated in public reviews

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vepdegestrant · Estrogen receptor (PROTAC degrader)
Not stated in public reviews

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vericiguat · Soluble guanylate cyclase
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Not stated in public reviews

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pitolisant · Histamine H3 receptor
Not stated in public reviews

Wayrilz

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belzutifan · HIF-2α
Not stated in public reviews

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Not stated in public reviews

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Not stated in public reviews

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Not stated in public reviews

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Not stated in public reviews

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Not stated in public reviews

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Not stated in public reviews

Zeposia

ozanimod · S1P1/S1P5 receptor
Not stated in public reviews

Zepzelca

lurbinectedin · DNA minor groove (transcription)
Not stated in public reviews

Zevtera

ceftobiprole medocaril · Penicillin-binding proteins
Not stated in public reviews

Zokinvy

lonafarnib · Farnesyltransferase
Not stated in public reviews

Zulresso

brexanolone · GABA-A receptor (positive modulator)
Not stated in public reviews

Zurzuvae

zuranolone · GABA-A receptor (positive modulator)
Not stated in public reviews

Zycubo

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Not stated in public reviews

Summary across all 211 small molecules →