Actemra
tocilizumab · IL-6R26 weeks
Andembry: how long were the pivotal tox studies?
garadacimab · Factor XIIa
Longest pivotal study
26 weeks
“The Applicant characterized the toxicity profile of garadacimab by conducting 4-week mouse and 26-week monkey toxicology studies with garadacimab using the IV and SC routes.”
Pivotal GLP studies
GLP 4-week CD-1 mouse and 26-week cynomolgus monkey studies, IV and SC; immunogenicity precluded longer mouse studies
“The Applicant characterized the toxicity profile of garadacimab by conducting 4-week mouse and 26-week monkey toxicology studies with garadacimab using the IV and SC routes. Immunogenicity in mice precluded conducting longer toxicology studies in this species.”
Route in tox
Intravenous and subcutaneous
“The Applicant characterized the toxicity profile of garadacimab by conducting 4-week mouse and 26-week monkey toxicology studies with garadacimab using the IV and SC routes.”
Same question, other monoclonal antibodies
Adakveo
crizanlizumab · P-selectin26 weeks
Adbry
tralokinumab · IL-1326 weeks
Aduhelm
aducanumab · Aggregated amyloid-β26 weeks
Aimovig
erenumab · CGRP receptor26 weeks
Ajovy
fremanezumab · CGRP26 weeks
Alhemo
concizumab · TFPI52 weeks
Anthim
obiltoxaximab · B. anthracis PA1 (dosing on Days 1, 4 and 7 in rats)
Arzerra
ofatumumab · CD2030 (7 months)
Avastin
bevacizumab · VEGF-A26 weeks
Bavencio
avelumab · PD-L113 weeks
Benlysta
belimumab · BLyS (BAFF)26 weeks
Beyfortus
nirsevimab · RSV F protein4 weeks
Bimzelx
bimekizumab · IL-17A/IL-17F26 weeks
Briumvi
ublituximab · CD2026 weeks
Cablivi
caplacizumab · von Willebrand factor (A1 domain)26 weeks
Campath
alemtuzumab · CD524 weeks
Cimzia
certolizumab pegol · TNF-α52 weeks
Cinqair
reslizumab · IL-526 weeks
Cosentyx
secukinumab · IL-17A26 weeks
Crysvita
burosumab · FGF2340 weeks
Cyramza
ramucirumab · VEGFR239 weeks
Danyelza
naxitamab · GD213 weeks
Darzalex
daratumumab · CD386 weeks
Dupixent
dupilumab · IL-4Ra26 weeks
Ebanga
ansuvimab · Zaire ebolavirus glycoprotein4 weeks
Ebglyss
lebrikizumab · IL-1339 weeks
Emgality
galcanezumab · CGRP26 weeks
Empliciti
elotuzumab · SLAMF70 (no repeat-dose toxicity studies)
Enflonsia
clesrovimab · RSV F protein (site IV)2 weeks
Enjaymo
sutimlimab · Complement C1s26 weeks
Enspryng
satralizumab · IL-6R26 weeks
Entyvio
vedolizumab · α4β7-integrin26 weeks
Erbitux
cetuximab · EGFR39 weeks
Evenity
romosozumab · Sclerostin26 weeks
Evkeeza
evinacumab · ANGPTL326 weeks
Exdensur
depemokimab · IL-526 weeks
Fasenra
benralizumab · IL-5Rα39 weeks
Gamifant
emapalumab · IFN-γ13 weeks
Gazyva
obinutuzumab · CD2026 weeks
Herceptin
trastuzumab · HER226 weeks
Humira
adalimumab · TNF-α39 weeks
Hympavzi
marstacimab · TFPI26 weeks
Ilaris
canakinumab · IL-1β26 weeks
Ilumya
tildrakizumab · IL-23 p1939 weeks
Imaavy
nipocalimab · FcRn26 weeks
Imfinzi
durvalumab · PD-L113 weeks
Imjudo
tremelimumab · CTLA-426 weeks
Jemperli
dostarlimab · PD-113 weeks
Kevzara
sarilumab · IL-6R26 weeks
Keytruda
pembrolizumab · PD-126 weeks
Kisunla
donanemab · Amyloid-β (N3pG)22 weeks
Lartruvo
olaratumab · PDGFRα39 weeks
Leqembi
lecanemab · Amyloid-β protofibrils39 weeks
Libtayo
cemiplimab · PD-126 weeks
Loqtorzi
toripalimab · PD-126 weeks
Lucentis
ranibizumab · VEGF-A26 weeks
Margenza
margetuximab · HER213 weeks
Monjuvi
tafasitamab · CD1913 weeks
Nemluvio
nemolizumab · IL-31RA26 weeks
Niktimvo
axatilimab · CSF-1R26 weeks
Nucala
mepolizumab · IL-526 weeks
Ocrevus
ocrelizumab · CD2024 weeks
Omvoh
mirikizumab · IL-23 p1926 weeks
Opdivo
nivolumab · PD-113 weeks
Pasatru
garetosmab · Activin A26 weeks
Penpulimab
penpulimab · PD-113 weeks
Perjeta
pertuzumab · HER226 weeks
Piasky
crovalimab · Complement C526 weeks
Portrazza
necitumumab · EGFR26 weeks
Poteligeo
mogamulizumab · CCR426 weeks
Praluent
alirocumab · PCSK926 weeks
Praxbind
idarucizumab · Dabigatran4 weeks
Prolia
denosumab · RANKL52 weeks
Raxibacumab
raxibacumab · B. anthracis protective antigen3 weeks
Remicade
infliximab · TNF-α26 (mouse surrogate antibody)
Repatha
evolocumab · PCSK926 weeks
Rituxan
rituximab · CD208 weeks
Rystiggo
rozanolixizumab · FcRn26 weeks
Saphnelo
anifrolumab · IFNAR139 weeks
Sarclisa
isatuximab · CD383 weeks
Siliq
brodalumab · IL-17RA26 weeks
Simponi
golimumab · TNF-α26 weeks
Simulect
basiliximab · IL-2Rα (CD25)4 weeks
Skyrizi
risankizumab · IL-23 p1926 weeks
Soliris
eculizumab · Complement C526 weeks
Spevigo
spesolimab · IL-36R26 weeks
Stelara
ustekinumab · IL-12/23 p4026 weeks
Sylvant
siltuximab · IL-626 weeks
Synagis
palivizumab · RSV F protein0 (no repeat-dose studies; single-dose only)
Takhzyro
lanadelumab · Plasma kallikrein26 weeks
Taltz
ixekizumab · IL-17A39 weeks
Tecentriq
atezolizumab · PD-L126 weeks
Tepezza
teprotumumab · IGF-1R39 weeks
Tevimbra
tislelizumab · PD-113 weeks
Tezspire
tezepelumab · TSLP26 weeks
Tremfya
guselkumab · IL-23 p1924 weeks
Trogarzo
ibalizumab · CD439 weeks
Tysabri
natalizumab · α4-integrin26 weeks
Tzield
teplizumab · CD31 weeks
Ultomiris
ravulizumab · Complement C526 weeks
Unituxin
dinutuximab · GD24 weeks
Unloxcyt
cosibelimab · PD-L113 weeks
Uplizna
inebilizumab · CD1926 weeks
Vectibix
panitumumab · EGFR26 weeks
Veopoz
pozelimab · Complement C526 weeks
Voyxact
sibeprenlimab · APRIL26 weeks
Vyepti
eptinezumab · CGRP26 weeks
Vyloy
zolbetuximab · Claudin 18.213 weeks
Xolair
omalizumab · IgE26 weeks
Yartemlea
narsoplimab · MASP-226 weeks
Yervoy
ipilimumab · CTLA-426 weeks
Zinbryta
daclizumab · IL-2Rα (CD25)39 weeks
Zinplava
bezlotoxumab · C. difficile toxin B3 weeks
Zynyz
retifanlimab · PD-113 weeks
Beovu
brolucizumab · VEGF-ANot stated in public reviews