Accrufer
ferric maltol · Iron replacementDog
Baxfendy: which tox species, and why?
baxdrostat · Aldosterone synthase (CYP11B2)
Species
Rat and cynomolgus monkey
“A comprehensive toxicology program was conducted in both rats and cynomolgus monkeys.”
Why that species
Monkey RAAS closely resembles human, making it pharmacologically relevant; rat is a low-potency responder species
“The cynomolgus monkey renin-angiotensin system closely resembles the human system, making it a relevant species for assessing pharmacodynamic efficacy and toxicity.”
Surrogate molecule
No surrogate; the clinical compound was tested
“Baxdrostat was evaluated in repeat-dose oral toxicology studies of up to 6 months in rats and 9 months in monkeys.”
Species: general tox
Rat and cynomolgus monkey
“A comprehensive toxicology program was conducted in both rats and cynomolgus monkeys.”
Species: DART
Rat and rabbit (embryo-fetal development)
“While baxdrostat had no effects on embryo-fetal development in rats or rabbits dosed through organogenesis at exposures up to 54‑fold (rat) and 29-fold (rabbit) the human dose of 2 mg, baxdrostat showed greatly reduced potency in rats compared to humans, which limits the interpretability of the rodent data.”
Species: carcinogenicity
Rat (2-year) and transgenic mouse (6-month)
“The carcinogenic potential of baxdrostat was evaluated in 6-month transgenic mouse and 2-year rat studies.”
Surrogate used in
No surrogate used; baxdrostat itself tested in rats and monkeys
“A comprehensive toxicology program was conducted in both rats and cynomolgus monkeys.”
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Anzupgo
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Artesunate
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Camzyos
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Caplyta
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Cosela
trilaciclib · CDK4/6Rat and dog
Crenessity
crinecerfont · CRF1 receptorRat and dog
Cypsedo
cipepofol · GABA-A receptorRat and dog
Daybue
trofinetide · IGF-1 tripeptide analogueRat and dog
Dayvigo
lemborexant · Orexin OX1/OX2 receptorsRat and monkey
Defencath
taurolidine and heparin · Antimicrobial catheter lockRat (14-day IV study) and mouse (single-dose IP study)
Dojolvi
triheptanoin · Anaplerotic energy substrateMinipig (GLP); published rat dietary study
Duvyzat
givinostat · Histone deacetylase (class I/II)Rat and monkey (supporting 13-week mouse and 4-week dog)
Egaten
triclabendazole · Fasciola (tubulin)Rat and dog
Ekterly
sebetralstat · Plasma kallikreinRat and cynomolgus monkey
Ensacove
ensartinib · ALKRat and dog
Evrysdi
risdiplam · SMN2 splicingRat and cynomolgus monkey
Exblifep
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Exkivity
mobocertinib · EGFR exon 20 insertionRat and dog
Exxua
gepirone · 5-HT1A receptorRat and dog
Fabhalta
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Fexinidazole
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Filspari
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Fotivda
tivozanib · VEGFR1-3Rat and cynomolgus monkey
Foundayo
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Fruzaqla
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Gavreto
pralsetinib · RETRat and cynomolgus monkey
Gemtesa
vibegron · β3-adrenergic receptorRat and cynomolgus monkey
Gomekli
mirdametinib · MEK1/2Rat and dog
Grafapex
treosulfan · DNA alkylationRat, dog and monkey
Hernexeos
zongertinib · HER2 (mutant)Rat and dog
Hyrnuo
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Ibsrela
tenapanor · NHE3Rat and dog
Ibtrozi
taletrectinib · ROS1Rat and cynomolgus monkey
Idvynso
doravirine and islatravir · NNRTI; NRTTIRat and rhesus monkey (islatravir), plus mouse up to 3 months
Inluriyo
imlunestrant · Estrogen receptor (SERD)Rat and cynomolgus monkey
Inpefa
sotagliflozin · SGLT1/SGLT2Rat and dog
Inqovi
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Inrebic
fedratinib · JAK2Rat and dog
Iqirvo
elafibranor · PPARα/δRat and cynomolgus monkey (mouse up to 3 months)
Isturisa
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Itovebi
inavolisib · PI3Kα (mutant-selective)Rat and dog
Jascayd
nerandomilast · PDE4BRat, minipig and cynomolgus monkey
Jaypirca
pirtobrutinib · BTK (non-covalent)Rat and dog
Jesduvroq
daprodustat · HIF prolyl hydroxylaseRat and cynomolgus monkey (dog in studies up to 13 weeks)
Jideytro
zidesamtinib · ROS1Rat and dog
Joenja
leniolisib · PI3KδRat and cynomolgus monkey
Journavx
suzetrigine · NaV1.8Rat and cynomolgus monkey
Kerendia
finerenone · Mineralocorticoid receptorRat and dog
Klisyri
tirbanibulin · Tubulin / SrcRat and dog (oral); minipig and rat (topical)
Komzifti
ziftomenib · Menin-KMT2AMouse and dog
Koselugo
selumetinib · MEK1/2Mouse, rat and cynomolgus monkey
Krazati
adagrasib · KRAS G12CRat and dog
Kygevvi
doxecitine and doxribtimine · Pyrimidine nucleoside replacement (TK2 deficiency)Rat and dog (plus 4-week mouse)
Lampit
nifurtimox · Trypanosoma cruziRat and dog
Lazcluze
lazertinib · EGFR (mutant-selective)Rat and dog
Leqselvi
deuruxolitinib · JAK1/JAK2Rat and dog
Lifyorli
relacorilant · Glucocorticoid receptor (antagonist)Rat and cynomolgus monkey
Litfulo
ritlecitinib · JAK3/TEC kinasesRat and dog
Livdelzi
seladelpar · PPARδRat and cynomolgus monkey (also mouse and dog)
Livmarli
maralixibat · IBAT (ASBT)Rat and dog
Livtencity
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Lumakras
sotorasib · KRAS G12CRat and dog
Lupkynis
voclosporin · CalcineurinRat and cynomolgus monkey
Lybalvi
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Lynavoy
linerixibat · IBATRat and dog
Lynkuet
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Lytgobi
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Mayzent
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Miebo
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Miplyffa
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Modeyso
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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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Nulibry
fosdenopterin · cPMP replacement (MoCD type A)Rat and dog (juvenile)
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Nuzolvence
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Ogsiveo
nirogacestat · Gamma secretaseRat and dog
Ohtuvayre
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Ojemda
tovorafenib · RAF (type II pan-RAF)Rat and cynomolgus monkey
Ojjaara
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Olinvyk
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Omlonti
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Ongentys
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Orgovyx
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Orladeyo
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Orlynvah
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Orserdu
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Orzeyful
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Paxlovid
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Pemazyre
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Piqray
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Pizensy
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Ponvory
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Pyrukynd
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Qelbree
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Qinlock
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Qulipta
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Quviviq
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Rapiblyk
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Relyvrio
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Revtorpyk
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Revuforj
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Reyvow
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Rezdiffra
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Rezlidhia
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Rezzayo
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Rhapsido
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Rinvoq
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Romvimza
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Rozlytrek
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Scemblix
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Sephience
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Simtriyo
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Skyclarys
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Sofdra
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Sotyktu
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Sunosi
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Tabrecta
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Trikafta
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Truqap
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Truseltiq
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Tryptyr
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Tryvio
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Tukysa
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Turalio
pexidartinib · CSF1RRat and dog
Ubrelvy
ubrogepant · CGRP receptorRat and rhesus monkey
Ukoniq
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Utebzi
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Vafseo
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Vanflyta
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Vanrafia
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Veklury
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Velsipity
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Veozah
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Veppanu
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Verquvo
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Vivjoa
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Vizz
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Vonjo
pacritinib · JAK2/FLT3Mouse and dog
Voquezna
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Voranigo
vorasidenib · IDH1/IDH2Rat and cynomolgus monkey
Voydeya
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Vtama
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Vyndaqel
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Wakix
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Wayrilz
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Welireg
belzutifan · HIF-2αRat and dog
Winlevi
clascoterone · Androgen receptor (topical)Rat and minipig
Xacduro
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Xcopri
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Xdemvy
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Xeglyze
abametapir · Lice metalloproteinasesRat and minipig
Xenleta
lefamulin · Bacterial ribosome (50S PTC)Rat and cynomolgus monkey
Xocova
ensitrelvir · SARS-CoV-2 3CL proteaseRat and cynomolgus monkey
Xolremdi
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Xpovio
selinexor · XPO1Rat and cynomolgus monkey
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Zaynich
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Zegfrovy
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Zenbexus
iberdomide · Cereblon (CELMoD)Rat and monkey
Zeposia
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Zepzelca
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Zevtera
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Zokinvy
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Ztalmy
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Zulresso
brexanolone · GABA-A receptor (positive modulator)Rat and dog
Zurzuvae
zuranolone · GABA-A receptor (positive modulator)Rat and dog
Zycubo
copper histidinate · Copper replacement (Menkes disease)Juvenile rat only