Accrufer
ferric maltol · Iron replacement4 (28-day dog)
Nubeqa: how long were the pivotal tox studies?
darolutamide · Androgen receptor
Longest pivotal study
39 (39-week dog)
“The Applicant conducted general toxicology studies to evaluate the effects of daily oral administration of darolutamide in rats for up to 26 weeks and in dogs for up to 39 weeks.”
Pivotal GLP studies
26-week rat and 39-week dog oral gavage studies with 4- and 8-week recovery
“Study title/ Study number : ODM-201-39-week oral (gavage) toxicity study in the Beagle dog followed by an 8-week treatment-free period/Study number AB19526.”
Route in tox
Oral gavage (twice daily)
“Study title/ number: ODM-201-26-week oral (gavage) toxicity study in the wistar rat followed by a 4-week treatment-free period/Study number AB14461”
Same question, other small molecules
Adquey
difamilast · PDE4 (topical)39 (39-week dog and minipig)
Agamree
vamorolone · Glucocorticoid receptor (dissociative)39 (9-month dog)
Alyftrek
vanzacaftor, tezacaftor and deutivacaftor · CFTR39 (39-week dog, vanzacaftor)
Anzupgo
delgocitinib · Pan-JAK (topical)39 (9-month oral dog and dermal minipig)
Aqneursa
levacetylleucine · Neuronal metabolism (proposed)39 (39-week dog)
Artesunate
artesunate · Plasmodium (antimalarial)4 (28-day rat and dog)
Attruby
acoramidis · Transthyretin (stabiliser)39 (39-week dog)
Augtyro
repotrectinib · ROS1/TRK13 (91-day rat and monkey)
Avmapki Fakzynja Co-pack
avutometinib and defactinib · RAF/MEK clamp; FAK13 (13-week rat, monkey and dog)
Ayvakit
avapritinib · KIT/PDGFRA39 (9-month dog)
Azstarys
serdexmethylphenidate and dexmethylphenidate · Dopamine/norepinephrine reuptake26 (6-month juvenile rabbit)
Balversa
erdafitinib · FGFR1-413 (13-week rat and dog)
Barhemsys
amisulpride · Dopamine D2/D3 receptor4 (28-day rat)
Baxfendy
baxdrostat · Aldosterone synthase (CYP11B2)39 (9-month monkey)
Beqalzi
sonrotoclax · BCL-213 weeks
Blujepa
gepotidacin · Bacterial topoisomerases (gyrase/topo IV)13 (13-week rat and dog)
Brenzavvy
bexagliflozin · SGLT239 (39-week monkey)
Brexafemme
ibrexafungerp · Fungal glucan synthase26 (26-week rat)
Brinsupri
brensocatib · DPP1 (cathepsin C)39 (9-month dog)
Brukinsa
zanubrutinib · BTK39 (9-month dog)
Byfavo
remimazolam · GABA-A receptor (benzodiazepine site)4 (4-week minipig and monkey)
Bylvay
odevixibat · IBAT39 (39-week dog)
Cabenuva
cabotegravir and rilpivirine · HIV-1 integrase; NNRTI39 (39-week monkey)
Camzyos
mavacamten · Cardiac myosin39 (9-month dog)
Caplyta
lumateperone · 5-HT2A / D2 receptor39 (9-month dog)
Cardamyst
etripamil · L-type calcium channel26 (6-month monkey)
Cibinqo
abrocitinib · JAK139 (9-month monkey)
Cobenfy
xanomeline and trospium · Muscarinic M1/M4 agonist; peripheral antagonist52 (1-year monkey, xanomeline)
Cosela
trilaciclib · CDK4/61 (7-day rat and dog iv)
Crenessity
crinecerfont · CRF1 receptor52 (12-month dog)
Cypsedo
cipepofol · GABA-A receptor4 (rat and dog, dosing every other day)
Daybue
trofinetide · IGF-1 tripeptide analogue39 (39-week dog)
Dayvigo
lemborexant · Orexin OX1/OX2 receptors39 (9-month monkey)
Defencath
taurolidine and heparin · Antimicrobial catheter lock2 (14-day rat; not considered pivotal)
Dojolvi
triheptanoin · Anaplerotic energy substrate39 (9-month juvenile minipig)
Duvyzat
givinostat · Histone deacetylase (class I/II)39 (39-week monkey)
Egaten
triclabendazole · Fasciola (tubulin)13 (13-week rat and dog)
Ekterly
sebetralstat · Plasma kallikrein26 (6-month rat and monkey)
Ensacove
ensartinib · ALK13 (13-week rat and dog)
Evrysdi
risdiplam · SMN2 splicing39 (39-week monkey)
Exblifep
cefepime and enmetazobactam · PBPs; beta-lactamase (enmetazobactam)13 (13-week dog combination study)
Exkivity
mobocertinib · EGFR exon 20 insertion13 (3-month rat and dog)
Exxua
gepirone · 5-HT1A receptor52 (12-month dog)
Fabhalta
iptacopan · Complement factor B39 (39-week dog)
Fetroja
cefiderocol · Penicillin-binding proteins13 (3-month rat and monkey)
Fexinidazole
fexinidazole · Trypanosoma brucei4 (28-day rat and dog)
Filspari
sparsentan · Endothelin A / angiotensin II receptors39 (39-week monkey)
Fotivda
tivozanib · VEGFR1-339 (39-week monkey)
Foundayo
orforglipron · GLP-1 receptor (non-peptide)39 (9-month monkey)
Fruzaqla
fruquintinib · VEGFR1-313 (13-week rat and dog GLP studies)
Gavreto
pralsetinib · RET13 (13-week rat and monkey)
Gemtesa
vibegron · β3-adrenergic receptor39 (9-month monkey)
Gomekli
mirdametinib · MEK1/213 (3-month rat and dog)
Grafapex
treosulfan · DNA alkylation4 (4-week rat GLP study)
Hernexeos
zongertinib · HER2 (mutant)13 (13-week rat and dog)
Hyrnuo
sevabertinib · HER2 (mutant)13 (13-week rat and monkey)
Ibsrela
tenapanor · NHE339 (9-month dog)
Ibtrozi
taletrectinib · ROS112 (85-day rat and monkey)
Idvynso
doravirine and islatravir · NNRTI; NRTTI39 (9-month monkey)
Inluriyo
imlunestrant · Estrogen receptor (SERD)26 (6-month rat)
Inpefa
sotagliflozin · SGLT1/SGLT239 (39-week dog)
Inqovi
decitabine and cedazuridine · DNMT (decitabine); cytidine deaminase (cedazuridine)13 (92-day monkey, 4 cycles)
Inrebic
fedratinib · JAK239 (9-month dog)
Iqirvo
elafibranor · PPARα/δ52 (12-month monkey)
Isturisa
osilodrostat · 11β-hydroxylase (CYP11B1)39 (39-week dog)
Itovebi
inavolisib · PI3Kα (mutant-selective)13 (3-month rat and dog)
Jascayd
nerandomilast · PDE4B39 (39-week minipig and monkey)
Jaypirca
pirtobrutinib · BTK (non-covalent)13 (3-month rat and dog)
Jesduvroq
daprodustat · HIF prolyl hydroxylase39 (39-week monkey)
Jideytro
zidesamtinib · ROS113 (13-week rat and dog)
Joenja
leniolisib · PI3Kδ39 (39-week monkey)
Journavx
suzetrigine · NaV1.813 (13-week rat and monkey)
Kerendia
finerenone · Mineralocorticoid receptor39 (9-month dog)
Klisyri
tirbanibulin · Tubulin / Src4 (28-day oral rat and dog)
Komzifti
ziftomenib · Menin-KMT2A13 (13-week mouse and dog)
Koselugo
selumetinib · MEK1/226 (26-week mouse and monkey)
Krazati
adagrasib · KRAS G12C13 (13-week rat and dog)
Kygevvi
doxecitine and doxribtimine · Pyrimidine nucleoside replacement (TK2 deficiency)26 (6-month juvenile rat)
Lampit
nifurtimox · Trypanosoma cruzi52 (52-week dog)
Lazcluze
lazertinib · EGFR (mutant-selective)13 (13-week rat and dog)
Leqselvi
deuruxolitinib · JAK1/JAK252 (52-week dog)
Lifyorli
relacorilant · Glucocorticoid receptor (antagonist)39 (39-week monkey)
Litfulo
ritlecitinib · JAK3/TEC kinases39 (39-week dog)
Livdelzi
seladelpar · PPARδ52 (52-week monkey)
Livmarli
maralixibat · IBAT (ASBT)52 (1-year dog)
Livtencity
maribavir · CMV UL97 protein kinase52 (52-week monkey)
Lumakras
sotorasib · KRAS G12C13 (3-month rat and dog)
Lupkynis
voclosporin · Calcineurin39 (39-week monkey)
Lybalvi
olanzapine and samidorphan · D2/5-HT2A; opioid receptors (samidorphan)39 (9-month dog, samidorphan)
Lynavoy
linerixibat · IBAT39 (39-week dog)
Lynkuet
elinzanetant · NK1/NK3 receptors39 (39-week monkey)
Lytgobi
futibatinib · FGFR1-4 (covalent)13 (13-week rat and dog)
Mayzent
siponimod · S1P1/S1P5 receptor52 (52-week monkey)
Miebo
perfluorohexyloctane · Tear film evaporation barrier26 (26-week rabbit ocular)
Miplyffa
arimoclomol · Heat-shock response amplifier52 (52-week dog)
Modeyso
dordaviprone · DRD2 antagonist / ClpP agonist13 (13-week rat and dog)
Myqorzo
aficamten · Cardiac myosin39 (39-week dog)
Nereus
tradipitant · NK1 receptor26 (6-month rat)
Nexletol
bempedoic acid · ATP citrate lyase52 (52-week monkey)
Nextstellis
drospirenone and estetrol · Estrogen / progestin receptors39 (39-week monkey)
Nourianz
istradefylline · Adenosine A2A receptor52 (52-week dog)
Nulibry
fosdenopterin · cPMP replacement (MoCD type A)39 (juvenile dog)
Nurtec ODT
rimegepant · CGRP receptor39 (9-month monkey)
Nuzolvence
zoliflodacin · Bacterial topoisomerase II4 (4-week rat and dog)
Ogsiveo
nirogacestat · Gamma secretase13 (3-month rat and dog)
Ohtuvayre
ensifentrine · PDE3/PDE440 (40-week dog)
Ojemda
tovorafenib · RAF (type II pan-RAF)13 (3-month rat and monkey)
Ojjaara
momelotinib · JAK1/JAK2/ACVR139 (39-week dog)
Olinvyk
oliceridine · μ-opioid receptor (G-protein biased)4 (28-day rat)
Omlonti
omidenepag isopropyl · EP2 receptor39 (39-week monkey topical ocular)
Ongentys
opicapone · COMT52 (52-week monkey)
Orgovyx
relugolix · GnRH receptor39 (39-week monkey)
Orladeyo
berotralstat · Plasma kallikrein39 (9-month monkey)
Orlynvah
sulopenem etzadroxil and probenecid · Penicillin-binding proteins4 (1-month rat and monkey)
Orserdu
elacestrant · Estrogen receptor (SERD)39 (39-week monkey)
Orzeyful
oveporexton · Orexin OX2 receptor agonist39 (39-week monkey)
Oxbryta
voxelotor · HbS polymerisation39 (39-week monkey)
Palsonify
paltusotine · Somatostatin receptor 239 (9-month dog)
Paxlovid
nirmatrelvir and ritonavir · SARS-CoV-2 Mpro (3CL protease)4 (1-month rat and monkey)
Pemazyre
pemigatinib · FGFR1-313 (3-month rat and monkey)
Piqray
alpelisib · PI3Kα13 (13-week rat and dog)
Pizensy
lactitol · Osmotic laxative13 (91-day rat)
Ponvory
ponesimod · S1P1 receptor52 (52-week dog)
Pretomanid
pretomanid · Mycobacterial cell wall / respiration39 (9-month monkey)
Pyrukynd
mitapivat · Pyruvate kinase (activator)39 (9-month monkey)
Qelbree
viloxazine · Norepinephrine reuptake78 (18-month rat)
Qinlock
ripretinib · KIT/PDGFRA13 (13-week rat and dog)
Qulipta
atogepant · CGRP receptor39 (9-month monkey)
Quviviq
daridorexant · Orexin OX1/OX2 receptors39 (39-week dog)
Rapiblyk
landiolol · β1-adrenergic receptor4 (4-week rat and dog studies)
Rasonque
daraxonrasib · RAS(ON) multi-selective13 (13-week mouse and monkey)
Recarbrio
imipenem, cilastatin and relebactam · Beta-lactamase (relebactam)13 (3-month rat and monkey)
Relyvrio
sodium phenylbutyrate and taurursodiol · ER stress / mitochondrial (proposed)39 (9-month minipig)
Retevmo
selpercatinib · RET13 weeks
Revtorpyk
gedatolisib · PI3K/mTOR13 (3-month rat and dog)
Revuforj
revumenib · Menin-KMT2A13 (13-week rat and dog)
Reyvow
lasmiditan · 5-HT1F receptor39 (39-week dog)
Rezdiffra
resmetirom · Thyroid hormone receptor β39 weeks
Rezlidhia
olutasidenib · IDH1 (mutant)13 (13-week rat and monkey)
Rezurock
belumosudil · ROCK239 (39-week dog)
Rezzayo
rezafungin · Fungal glucan synthase26 (26-week rat and monkey)
Rhapsido
remibrutinib · BTK39 (39-week dog)
Rinvoq
upadacitinib · JAK139 (39-week dog)
Romvimza
vimseltinib · CSF1R39 (39-week dog)
Rozlytrek
entrectinib · TRK/ROS1/ALK13 (13-week rat and dog)
Rukobia
fostemsavir · HIV-1 gp120 (attachment)39 (9-month dog)
Scemblix
asciminib · BCR-ABL1 (STAMP, myristoyl pocket)39 (39-week monkey)
Sephience
sepiapterin · Tetrahydrobiopterin precursor39 (39-week marmoset)
Simtriyo
centanafadine · Triple monoamine reuptake43 (43-week juvenile dog)
Skyclarys
omaveloxolone · Nrf2 activator39 (39-week monkey)
Sofdra
sofpironium · Muscarinic receptors (topical)39 (39-week dermal minipig)
Sohonos
palovarotene · RARγ39 (39-week dog)
Sotyktu
deucravacitinib · TYK239 (9-month monkey)
Sunlenca
lenacapavir · HIV-1 capsid39 (9-month dog)
Sunosi
solriamfetol · Dopamine/norepinephrine reuptake52 (12-month dog)
Tabrecta
capmatinib · MET13 (13-week rat and monkey)
Tavneos
avacopan · C5a receptor (C5aR1)44 (44-week monkey)
Tazverik
tazemetostat · EZH213 (13-week rat and monkey)
Tepmetko
tepotinib · MET39 (39-week dog)
Trikafta
elexacaftor, tezacaftor and ivacaftor · CFTR39 (39-week dog, elexacaftor)
Truqap
capivasertib · AKT1-339 (9-month dog)
Truseltiq
infigratinib · FGFR1-339 (39-week dog)
Tryptyr
acoltremon · TRPM8 agonist26 (6-month rabbit and dog ocular)
Tryvio
aprocitentan · Endothelin A/B receptors39 (39-week dog)
Tukysa
tucatinib · HER213 weeks
Turalio
pexidartinib · CSF1R39 (9-month dog)
Ubrelvy
ubrogepant · CGRP receptor39 (9-month monkey)
Ukoniq
umbralisib · PI3Kδ / CK1ε39 (39-week dog)
Utebzi
tebipenem pivoxil · Penicillin-binding proteins4 (28-day GLP rat and monkey; non-GLP studies up to 90 days)
Vafseo
vadadustat · HIF prolyl hydroxylase39 (9-month dog)
Vanflyta
quizartinib · FLT313 (13-week rat, dog and monkey)
Vanrafia
atrasentan · Endothelin A receptor39 (9-month dog)
Veklury
remdesivir · SARS-CoV-2 RNA polymerase4 (4-week rat and monkey)
Velsipity
etrasimod · S1P1/S1P4/S1P5 receptors39 (9-month dog)
Veozah
fezolinetant · Neurokinin-3 receptor39 (39-week monkey)
Veppanu
vepdegestrant · Estrogen receptor (PROTAC degrader)39 (9-month dog)
Verquvo
vericiguat · Soluble guanylate cyclase39 (39-week dog)
Vivjoa
oteseconazole · Fungal CYP5139 (9-month dog)
Vizz
aceclidine · Muscarinic agonist (miotic)26 (6-month rabbit ocular)
Vonjo
pacritinib · JAK2/FLT339 (39-week dog)
Voquezna
vonoprazan · H+/K+-ATPase (potassium-competitive)39 (39-week dog)
Voranigo
vorasidenib · IDH1/IDH213 (13-week rat and monkey)
Voydeya
danicopan · Complement factor D39 (39-week dog)
Vtama
tapinarof · Aryl hydrocarbon receptor39 (9-month minipig)
Vyndaqel
tafamidis · Transthyretin (stabiliser)39 (39-week dog)
Wakix
pitolisant · Histamine H3 receptor39 (9-month monkey)
Wayrilz
rilzabrutinib · BTK (reversible covalent)39 (9-month dog)
Welireg
belzutifan · HIF-2α13 (3-month rat and dog)
Winlevi
clascoterone · Androgen receptor (topical)39 (39-week dermal minipig)
Xacduro
sulbactam and durlobactam · PBPs; beta-lactamase (durlobactam)4 (28-day dog)
Xcopri
cenobamate · Sodium channel / GABA-A52 (52-week monkey)
Xdemvy
lotilaner · Mite GABA-Cl channel39 (9-month dog ocular)
Xeglyze
abametapir · Lice metalloproteinases4 (28-day minipig dermal)
Xenleta
lefamulin · Bacterial ribosome (50S PTC)13 (13-week IV studies)
Xocova
ensitrelvir · SARS-CoV-2 3CL protease4 (4-week rat and monkey)
Xolremdi
mavorixafor · CXCR439 (39-week dog)
Xpovio
selinexor · XPO113 (13-week rat and monkey)
Zavzpret
zavegepant · CGRP receptor39 (39-week monkey)
Zaynich
cefepime and zidebactam · PBPs; beta-lactam enhancer (zidebactam)13 (13-week dog)
Zegfrovy
sunvozertinib · EGFR exon 20 insertion13 (13-week rat and dog)
Zenbexus
iberdomide · Cereblon (CELMoD)39 (9-month cynomolgus monkey)
Zeposia
ozanimod · S1P1/S1P5 receptor39 (39-week monkey)
Zepzelca
lurbinectedin · DNA minor groove (transcription)24 (8-cycle q3w rat and monkey)
Zevtera
ceftobiprole medocaril · Penicillin-binding proteins13 (13-week rat, marmoset and dog)
Zokinvy
lonafarnib · Farnesyltransferase52 (1-year monkey)
Ztalmy
ganaxolone · GABA-A receptor (positive modulator)52 (12-month dog)
Zulresso
brexanolone · GABA-A receptor (positive modulator)4 weeks
Zurzuvae
zuranolone · GABA-A receptor (positive modulator)39 (9-month dog)
Zycubo
copper histidinate · Copper replacement (Menkes disease)13 (13-week juvenile rat)