Accrufer
ferric maltol · Iron replacementDog
Orserdu: which tox species, and why?
elacestrant · Estrogen receptor (SERD)
Species
Rat and cynomolgus monkey
“Repeat dose toxicology studies were conducted with elacestrant in rats and monkeys for up to 26 and 39 weeks, respectively, administered via daily oral gavage”
Why that species
Monkey chosen as non-rodent because its reproductive system morphology, hormonal changes and menstrual cycle closely resemble humans
“The Applicant provided a justification for the use of non-human primates as non-rodent species, indicating that morphological and hormonal changes in the reproductive system and menstrual cycle phases of monkeys closely resemble those of humans.”
Surrogate molecule
No surrogate; the clinical compound was tested
“Repeat dose toxicology studies were conducted with elacestrant in rats and monkeys for up to 26 and 39 weeks, respectively, administered via daily oral gavage”
Species: general tox
Rat (26-week) and cynomolgus monkey (39-week)
“Repeat dose toxicology studies were conducted with elacestrant in rats and monkeys for up to 26 and 39 weeks, respectively, administered via daily oral gavage”
Species: DART
Rat (EFD only); fertility and pre/postnatal studies not conducted per ICH S9
“The Applicant assessed the effects of elacestrant on reproductive organs in the rat and monkey as part of the GLP-compliant repeat-dose toxicology studies and provided results from a GLP-compliant embryofetal development (EFD) study in rats.”
Species: carcinogenicity
Not conducted (ICH S9)
“Carcinogenicity studies were not conducted with elacestrant in accordance with ICH S9 guidance”
Surrogate used in
No surrogate used; elacestrant tested directly
“Repeat dose toxicology studies were conducted with elacestrant in rats and monkeys for up to 26 and 39 weeks, respectively, administered via daily oral gavage”
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Bylvay
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Camzyos
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Caplyta
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Cardamyst
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Cosela
trilaciclib · CDK4/6Rat and dog
Crenessity
crinecerfont · CRF1 receptorRat and dog
Cypsedo
cipepofol · GABA-A receptorRat and dog
Daybue
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Dayvigo
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Defencath
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Dojolvi
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Duvyzat
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Egaten
triclabendazole · Fasciola (tubulin)Rat and dog
Ekterly
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Evrysdi
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Exblifep
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Exxua
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Fabhalta
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Fexinidazole
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Filspari
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Foundayo
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Fruzaqla
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Gavreto
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Gemtesa
vibegron · β3-adrenergic receptorRat and cynomolgus monkey
Gomekli
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Grafapex
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Hyrnuo
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Ibsrela
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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
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Inqovi
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Inrebic
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Iqirvo
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Isturisa
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Itovebi
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Jascayd
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Jaypirca
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Jesduvroq
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Jideytro
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Joenja
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Journavx
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Kerendia
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Klisyri
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Komzifti
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Koselugo
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Krazati
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Kygevvi
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Lampit
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Lazcluze
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Leqselvi
deuruxolitinib · JAK1/JAK2Rat and dog
Lifyorli
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Litfulo
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Livdelzi
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Livmarli
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Livtencity
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Lumakras
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Lupkynis
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Lybalvi
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Lynavoy
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Lynkuet
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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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Ohtuvayre
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Ojjaara
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Olinvyk
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Ongentys
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Orgovyx
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Orladeyo
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Orlynvah
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Orzeyful
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Palsonify
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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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Rapiblyk
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Sofdra
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Sotyktu
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Sunlenca
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Tabrecta
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Truqap
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Tryptyr
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Tryvio
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Tukysa
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Turalio
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Ubrelvy
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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
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Voquezna
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Voranigo
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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
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Winlevi
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Xacduro
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Xcopri
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Xdemvy
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Xeglyze
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Xenleta
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Xocova
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Xpovio
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Zenbexus
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Zepzelca
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Zokinvy
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Ztalmy
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Zulresso
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Zurzuvae
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Zycubo
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