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Atlas/Small molecules/Nurtec ODT/Skipped studies

Nurtec ODT: genotox, carcinogenicity and repro: done or skipped?

rimegepant · CGRP receptor
Check my plan vs. these
Genotoxicity
Negative in Ames, in vitro chromosome aberration and rat bone marrow micronucleus assays
“BHV-3000 was negative in Ames, chromosomal aberration, and rat bone marrow micronucleus assays.”
✓ VerifiedFDA pharmacology/toxicology review, p. 58Source ↗
Carcinogenicity
26-week Tg.rasH2 mouse and 2-year rat: no drug-induced tumors
“Based on a review by the CDER Division of Biometrics, BHV-3000 did not induce tumor formation in the 26-week and 2-year carcinogenicity studies in TgRasH2 mice (0, 30, 100 300 mg/kg) and SD rats (0, 5, 15, 45 mg/kg), respectively.”
✓ VerifiedFDA pharmacology/toxicology review, p. 58Source ↗
Reproductive & developmental
Rat fertility: uterine atrophy >25 mg/kg, reduced conception at 150 mg/kg; no embryofetal toxicity in rat or rabbit
“Two fertility studies in SD rat indicated uterine atrophy at doses greater than 25 mg/kg, and decreased conception and increased pre-implantation loss at 150 mg/kg. There was no embryofetal toxicity in rat or rabbit.”
✓ VerifiedFDA pharmacology/toxicology review, p. 9Source ↗
Safety pharmacology
No CNS, cardiovascular or respiratory effects; hERG and sodium channel IC50 >30 µM
“There were no effects of BHV-3000 on CNS, cardiovascular, or respiratory safety pharmacology endpoints, and the IC50 for hERG or sodium ion channels was estimated to be in excess of 30 uM.”
✓ VerifiedFDA pharmacology/toxicology review, p. 9Source ↗

Same question, other small molecules

Accrufer

ferric maltol · Iron replacement
Ferric maltol positive in Ames; maltol positive in Ames and in vivo mouse micronucleus assay

Adquey

difamilast · PDE4 (topical)
Negative in Ames, mouse lymphoma and rat micronucleus assays

Agamree

vamorolone · Glucocorticoid receptor (dissociative)
Negative in Ames, mouse lymphoma gene mutation and mouse micronucleus assays

Alyftrek

vanzacaftor, tezacaftor and deutivacaftor · CFTR
Vanzacaftor negative in Ames, in vitro TK6 micronucleus and in vivo rat micronucleus assays

Anzupgo

delgocitinib · Pan-JAK (topical)
Ames negative; polyploidy in human lymphocytes in vitro; negative in vivo rat bone marrow chromosome aberration assay

Aqneursa

levacetylleucine · Neuronal metabolism (proposed)
Negative in Ames, in vitro human lymphocyte chromosome aberration and in vivo rat bone marrow assays

Artesunate

artesunate · Plasmodium (antimalarial)
Negative in Ames, CHO chromosome aberration and in vivo micronucleus assays

Attruby

acoramidis · Transthyretin (stabiliser)
Negative in Ames, rat micronucleus and alkaline comet assays

Augtyro

repotrectinib · ROS1/TRK
Ames negative; genotoxic via aneugenic mechanism in vitro (TK6 cells) and in vivo rat bone marrow micronucleus assay

Avmapki Fakzynja Co-pack

avutometinib and defactinib · RAF/MEK clamp; FAK
Defactinib: Ames and chromosome aberration negative; positive in vitro and in vivo rat micronucleus (aneugenic)

Ayvakit

avapritinib · KIT/PDGFRA
Ames negative; positive in vitro chromosome aberration; negative rat bone marrow micronucleus; overall non-genotoxic

Azstarys

serdexmethylphenidate and dexmethylphenidate · Dopamine/norepinephrine reuptake
Negative in Ames, in vitro human lymphocyte micronucleus, in vivo rat bone marrow micronucleus and rat comet assays

Balversa

erdafitinib · FGFR1-4
Negative in Ames, in vitro micronucleus and in vivo rat bone marrow micronucleus assays

Barhemsys

amisulpride · Dopamine D2/D3 receptor
Negative in Ames, in vitro human lymphocyte chromosome aberration and rat micronucleus assays

Baxfendy

baxdrostat · Aldosterone synthase (CYP11B2)
Not genotoxic in a battery of in vitro and in vivo assays

Beqalzi

sonrotoclax · BCL-2
Negative in Ames, in vitro chromosomal aberration and mouse bone marrow micronucleus assays

Blujepa

gepotidacin · Bacterial topoisomerases (gyrase/topo IV)
Positive in vitro (human lymphocyte micronucleus, mouse lymphoma); negative in vivo rat micronucleus and comet assays

Brenzavvy

bexagliflozin · SGLT2
Negative in Ames, in vitro CHO chromosomal aberration, in vivo rat micronucleus and rat unscheduled DNA synthesis assays

Brexafemme

ibrexafungerp · Fungal glucan synthase
Negative in Ames, in vitro chromosome aberration and rat bone marrow micronucleus assays

Brinsupri

brensocatib · DPP1 (cathepsin C)
Negative in Ames, in vitro mouse lymphoma TK and in vivo rat micronucleus assays

Brukinsa

zanubrutinib · BTK
Negative in Ames, in vitro chromosomal aberration and rat bone marrow micronucleus assays

Byfavo

remimazolam · GABA-A receptor (benzodiazepine site)
Negative in Ames, mouse lymphoma and in vivo rat micronucleus assays

Bylvay

odevixibat · IBAT
Negative in Ames, in vitro mouse lymphoma and in vivo rat micronucleus assays

Cabenuva

cabotegravir and rilpivirine · HIV-1 integrase; NNRTI
Negative in Ames and in vivo rat micronucleus assays

Camzyos

mavacamten · Cardiac myosin
Negative in Ames, human lymphocyte clastogenicity and rat micronucleus assays

Caplyta

lumateperone · 5-HT2A / D2 receptor
Ames and mouse lymphoma positive only with metabolic activation; negative rat micronucleus and Comet

Cardamyst

etripamil · L-type calcium channel
Negative in Ames, in vitro chromosome aberration and in vivo rat micronucleus (IV) assays

Cibinqo

abrocitinib · JAK1
Ames negative; aneugenic in in vitro micronucleus assay; negative in vivo rat micronucleus

Cobenfy

xanomeline and trospium · Muscarinic M1/M4 agonist; peripheral antagonist
Xanomeline negative in Ames, mouse lymphoma, rat hepatocyte UDS, CHO chromosome aberration and mouse micronucleus assays

Cosela

trilaciclib · CDK4/6
Ames negative; negative for clastogenicity in human fibroblasts; increased micronuclei in human lymphocytes in vitro

Crenessity

crinecerfont · CRF1 receptor
Negative in Ames, in vitro chromosomal aberration and in vivo rat bone marrow micronucleus assays

Cypsedo

cipepofol · GABA-A receptor
Negative in Ames, in vitro chromosomal aberration and mouse bone marrow micronucleus assays

Daybue

trofinetide · IGF-1 tripeptide analogue
Negative in Ames, in vitro CHO chromosomal aberration and in vivo mouse micronucleus assays

Dayvigo

lemborexant · Orexin OX1/OX2 receptors
Negative in Ames, mouse lymphoma TK and in vivo rat micronucleus assays

Defencath

taurolidine and heparin · Antimicrobial catheter lock
Taurolidine positive in vitro (mouse lymphoma and Ames) regardless of metabolic activation; negative in vivo

Dojolvi

triheptanoin · Anaplerotic energy substrate
Negative in Ames, in vitro chromosome aberration (human lymphocytes) and in vivo rat micronucleus assays

Duvyzat

givinostat · Histone deacetylase (class I/II)
Positive in Ames; negative in mouse lymphoma, human lymphocyte chromosome aberration and in vivo Big Blue rat (Pig-a) assays

Egaten

triclabendazole · Fasciola (tubulin)
Negative in a 6-assay battery including Ames, chromosome aberration and micronucleus assays

Ekterly

sebetralstat · Plasma kallikrein
Negative in Ames, mouse lymphoma and in vivo rat micronucleus assays

Ensacove

ensartinib · ALK
Negative in Ames, in vitro human lymphocyte chromosome aberration and in vivo rat micronucleus assays

Evrysdi

risdiplam · SMN2 splicing
Ames negative; clastogenic (micronucleus) in vitro in mouse lymphoma cells and in vivo in rat bone marrow

Exblifep

cefepime and enmetazobactam · PBPs; beta-lactamase (enmetazobactam)
Enmetazobactam negative in Ames, CHO chromosomal aberration and mouse bone marrow micronucleus assays

Exkivity

mobocertinib · EGFR exon 20 insertion
Negative in Ames, in vitro chromosome aberration (human lymphocytes) and in vivo rat bone marrow micronucleus assays

Exxua

gepirone · 5-HT1A receptor
Negative in Ames, CHO/HGPRT, hepatocyte DNA repair, rat micronucleus and 5-hour CHO chromosome aberration assays

Fabhalta

iptacopan · Complement factor B
Not genotoxic or mutagenic in a battery of in vitro and in vivo assays

Fetroja

cefiderocol · Penicillin-binding proteins
Ames negative; chromosomal aberrations in vitro; negative in vivo rat micronucleus and liver comet assays

Fexinidazole

fexinidazole · Trypanosoma brucei
Positive in Ames; negative in in vitro human lymphocyte micronucleus and in vivo mouse bone marrow micronucleus assays

Filspari

sparsentan · Endothelin A / angiotensin II receptors
Negative in Ames, in vitro chromosomal aberration and in vivo rat micronucleus assays

Fotivda

tivozanib · VEGFR1-3
Negative in Ames, in vitro CHO cytogenetic and in vivo mouse bone marrow micronucleus assays

Foundayo

orforglipron · GLP-1 receptor (non-peptide)
Negative in Ames, in vitro micronucleus (human lymphoblastoid cells) and in vivo rat bone marrow micronucleus assays

Fruzaqla

fruquintinib · VEGFR1-3
Negative in Ames, in vitro CHO chromosome aberration and in vivo rat micronucleus assays

Gavreto

pralsetinib · RET
Negative in Ames, in vitro TK6 micronucleus and rat bone marrow micronucleus assays

Gemtesa

vibegron · β3-adrenergic receptor
Negative in Ames, human lymphocyte chromosome aberration and rat bone marrow micronucleus assays

Gomekli

mirdametinib · MEK1/2
Negative Ames; not clastogenic in vitro or in rat chromosome aberration assay; positive rat micronucleus

Grafapex

treosulfan · DNA alkylation
Mutagenic in Ames test and clastogenic in in vitro human lymphocyte micronucleus assay

Hernexeos

zongertinib · HER2 (mutant)
Negative in Ames and rat in vivo micronucleus/comet (liver, duodenum) assays

Hyrnuo

sevabertinib · HER2 (mutant)
Negative in Ames, in vitro micronucleus and in vivo rat micronucleus assays

Ibsrela

tenapanor · NHE3
Negative in Ames, human lymphocyte chromosome aberration and in vivo micronucleus assays

Ibtrozi

taletrectinib · ROS1
Negative in Ames and additional mutagenicity tests and in the rat bone marrow/liver micronucleus assay

Idvynso

doravirine and islatravir · NNRTI; NRTTI
Islatravir: in vitro CHO chromosomal aberrations (mitigated by inosine); negative Ames and in vivo rat micronucleus

Inluriyo

imlunestrant · Estrogen receptor (SERD)
Ames negative; positive in vitro micronucleus; negative in vivo rat comet and bone marrow micronucleus assays

Inpefa

sotagliflozin · SGLT1/SGLT2
Negative in Ames, in vitro CHO chromosomal aberration and in vivo rat bone marrow micronucleus assays

Inqovi

decitabine and cedazuridine · DNMT (decitabine); cytidine deaminase (cedazuridine)
Cedazuridine positive in Ames and in vitro chromosome aberration assays; negative in in vivo micronucleus

Inrebic

fedratinib · JAK2
Negative in Ames, in vitro CHO chromosomal aberration and rat micronucleus assays

Iqirvo

elafibranor · PPARα/δ
Negative in Ames, rat micronucleus and rat comet assays; positive in mouse lymphoma cells

Isturisa

osilodrostat · 11β-hydroxylase (CYP11B1)
Ames and micronucleus negative; structural aberrations in in vitro chromosome aberration assay

Itovebi

inavolisib · PI3Kα (mutant-selective)
Ames negative; clastogenic in vitro (human lymphocyte micronucleus); negative in vivo rat bone marrow micronucleus and liver comet

Jascayd

nerandomilast · PDE4B
Negative in Ames, in vitro chromosome aberration and in vivo micronucleus assays

Jaypirca

pirtobrutinib · BTK (non-covalent)
Ames negative; aneugenic in in vitro human lymphocyte micronucleus assays; negative in in vivo rat bone marrow micronucleus assay

Jesduvroq

daprodustat · HIF prolyl hydroxylase
Negative in Ames, in vitro human lymphocyte chromosomal aberration and in vivo rat bone marrow micronucleus assays

Jideytro

zidesamtinib · ROS1
Positive in in vivo rat micronucleus assays; negative in Ames and in vitro TK6 clastogenicity assay

Joenja

leniolisib · PI3Kδ
Negative in Ames, in vitro chromosomal aberration, in vitro TK6 micronucleus and in vivo rat micronucleus assays

Journavx

suzetrigine · NaV1.8
Negative in Ames, in vitro TK6 micronucleus and in vivo rat bone marrow micronucleus assays

Kerendia

finerenone · Mineralocorticoid receptor
Negative in Ames, in vitro chromosomal aberration and in vivo mouse micronucleus assays

Klisyri

tirbanibulin · Tubulin / Src
Genotoxic: Ames negative; positive in CHO chromosome aberration, mouse lymphoma and rat micronucleus assays

Komzifti

ziftomenib · Menin-KMT2A
Negative in Ames, in vitro micronucleus and in vivo mouse bone marrow micronucleus assays

Koselugo

selumetinib · MEK1/2
Not mutagenic or clastogenic in vitro; positive (aneugenic) mouse micronucleus at >160 mg/kg (~38x human Cmax)

Krazati

adagrasib · KRAS G12C
Negative in Ames, in vitro chromosomal aberration and in vivo rat micronucleus assays

Kygevvi

doxecitine and doxribtimine · Pyrimidine nucleoside replacement (TK2 deficiency)
Negative in Ames and rat micronucleus; positive in vitro chromosome aberration assay in human lymphocytes

Lampit

nifurtimox · Trypanosoma cruzi
Considered genotoxic by weight of evidence; labeled with a genotoxicity Warning

Lazcluze

lazertinib · EGFR (mutant-selective)
Negative in Ames, in vitro chromosome aberration (CHL cells) and rat bone marrow micronucleus assays

Leqselvi

deuruxolitinib · JAK1/JAK2
Negative in Ames, in vitro chromosome aberration and rat bone marrow micronucleus; positive in vitro micronucleus (likely aneugenic)

Lifyorli

relacorilant · Glucocorticoid receptor (antagonist)
Negative in Ames, in vitro human lymphocyte micronucleus and in vivo rat micronucleus assays

Litfulo

ritlecitinib · JAK3/TEC kinases
Aneugenic in in vitro TK6 micronucleus assay; Ames negative

Livdelzi

seladelpar · PPARδ
Negative in Ames, mouse lymphoma and in vivo mouse micronucleus assays

Livmarli

maralixibat · IBAT (ASBT)
Negative in Ames, in vitro CHO chromosome aberration and in vivo rat micronucleus assays

Livtencity

maribavir · CMV UL97 protein kinase
Negative in Ames and in vivo rat micronucleus; mutagenic without metabolic activation in mouse lymphoma assay; overall not genotoxic

Lumakras

sotorasib · KRAS G12C
Negative in Ames and in vivo rat micronucleus and comet assays; some in vitro micronucleus induction

Lupkynis

voclosporin · Calcineurin
Negative in Ames, CHO chromosomal aberration and rat in vivo micronucleus assays

Lybalvi

olanzapine and samidorphan · D2/5-HT2A; opioid receptors (samidorphan)
Samidorphan negative in a standard genotoxicity battery

Lynavoy

linerixibat · IBAT
Negative in Ames, in vitro CHO chromosome aberration and in vivo rat micronucleus assays

Lynkuet

elinzanetant · NK1/NK3 receptors
Negative in Ames, mouse lymphoma and rat bone marrow micronucleus assays

Lytgobi

futibatinib · FGFR1-4 (covalent)
Negative Ames; clastogenic in vitro chromosome aberration assay; negative rat micronucleus and comet assays

Mayzent

siponimod · S1P1/S1P5 receptor
Negative in Ames, mammalian cell assays and mouse and rat micronucleus assays

Miebo

perfluorohexyloctane · Tear film evaporation barrier
Negative in Ames, in vitro human lymphocyte chromosome aberration and in vivo rat bone marrow micronucleus assays

Miplyffa

arimoclomol · Heat-shock response amplifier
Negative in Ames, mouse lymphoma forward mutation and in vivo mouse micronucleus assays

Modeyso

dordaviprone · DRD2 antagonist / ClpP agonist
Negative in Ames, in vitro and in vivo micronucleus assays

Myqorzo

aficamten · Cardiac myosin
Negative in Ames, combined in vivo micronucleus and comet assays

Nereus

tradipitant · NK1 receptor
Negative in Ames, in vitro human lymphocyte chromosomal aberration and mouse micronucleus assays

Nexletol

bempedoic acid · ATP citrate lyase
Ames negative; chromosome aberrations in human lymphocytes only with S9 at cytotoxic concentration

Nextstellis

drospirenone and estetrol · Estrogen / progestin receptors
Estetrol negative in Ames, mouse lymphoma, rat micronucleus and rat Comet assays (weight of evidence)

Nourianz

istradefylline · Adenosine A2A receptor
Negative in Ames (4 assays), CHL chromosome aberration, mouse micronucleus and rat UDS assays

Nubeqa

darolutamide · Androgen receptor
Negative Ames and in vivo rat micronucleus/comet; clastogenic in vitro in human lymphocytes; overall no genotoxic risk

Nulibry

fosdenopterin · cPMP replacement (MoCD type A)
Negative in the standard ICH S2(R1) battery, in vitro and in vivo

Nuzolvence

zoliflodacin · Bacterial topoisomerase II
Negative in mouse lymphoma and rat micronucleus assays; Ames positive in TA102, consistent with mechanism

Ogsiveo

nirogacestat · Gamma secretase
Negative in Ames, in vitro human chromosome aberration and in vivo rat bone marrow micronucleus assays

Ohtuvayre

ensifentrine · PDE3/PDE4
Negative in Ames, in vivo rat comet (lung and liver) and mouse micronucleus assays

Ojemda

tovorafenib · RAF (type II pan-RAF)
Not genotoxic overall: in vitro chromosomal aberrations only at precipitating concentrations; in vivo micronucleus negative

Ojjaara

momelotinib · JAK1/JAK2/ACVR1
Negative in Ames, human lymphocyte chromosome aberration and in vivo micronucleus assays

Olinvyk

oliceridine · μ-opioid receptor (G-protein biased)
Negative in Ames, in vitro chromosome aberration and rat micronucleus assays

Omlonti

omidenepag isopropyl · EP2 receptor
Negative in Ames and in vivo micronucleus; positive (mutagenic and clastogenic) in in vitro mouse lymphoma assay

Ongentys

opicapone · COMT
Negative in Ames, in vitro chromosome aberration (human lymphocytes) and mouse micronucleus assays

Orgovyx

relugolix · GnRH receptor
Negative in Ames, in vitro chromosome aberration and rat bone marrow micronucleus assays

Orladeyo

berotralstat · Plasma kallikrein
Negative in Ames, in vitro human lymphocyte chromosomal aberration and rat micronucleus assays

Orlynvah

sulopenem etzadroxil and probenecid · Penicillin-binding proteins
Ames negative; chromosome aberrations positive in vitro; negative in vivo rat bone marrow micronucleus

Orserdu

elacestrant · Estrogen receptor (SERD)
Negative in Ames, in vitro chromosome aberration and in vivo rat bone marrow micronucleus assays

Orzeyful

oveporexton · Orexin OX2 receptor agonist
Negative in Ames and in vivo micronucleus; positive in vitro micronucleus (24-hour); overall non-genotoxic

Oxbryta

voxelotor · HbS polymerisation
Negative in Ames, rat Comet and rat micronucleus assays

Palsonify

paltusotine · Somatostatin receptor 2
Negative in Ames, in vitro CHO micronucleus and in vivo rat bone marrow micronucleus assays

Paxlovid

nirmatrelvir and ritonavir · SARS-CoV-2 Mpro (3CL protease)
Nirmatrelvir negative in Ames, in vitro TK6 micronucleus and in vivo rat micronucleus assays

Pemazyre

pemigatinib · FGFR1-3
Negative in Ames, in vitro chromosome aberration (human lymphocytes) and rat bone marrow micronucleus assays

Piqray

alpelisib · PI3Kα
Negative in Ames, in vitro micronucleus and chromosome aberration, and in vivo rat micronucleus assays

Pizensy

lactitol · Osmotic laxative
Not conducted by the applicant; published studies negative in Ames, chromosome aberration and in vivo mouse micronucleus tests

Ponvory

ponesimod · S1P1 receptor
Negative in Ames, in vitro chromosomal aberration and rat micronucleus assays

Pretomanid

pretomanid · Mycobacterial cell wall / respiration
Negative in conventional genotoxicity battery; circulating metabolite M50 mutagenic in Ames

Pyrukynd

mitapivat · Pyruvate kinase (activator)
Negative in Ames, in vitro human lymphocyte micronucleus and in vivo rat bone marrow micronucleus assays

Qelbree

viloxazine · Norepinephrine reuptake
Negative in Ames, in vitro chromosomal aberration and rat bone marrow micronucleus assays

Qinlock

ripretinib · KIT/PDGFRA
Negative in Ames, in vitro chromosomal aberration, and in vivo rat micronucleus and comet assays

Qulipta

atogepant · CGRP receptor
Negative in Ames, in vitro chromosomal aberration and in vivo rat bone marrow micronucleus assays

Quviviq

daridorexant · Orexin OX1/OX2 receptors
Negative in Ames, in vitro chromosome aberration (human lymphocytes) and in vivo rat micronucleus assays

Rapiblyk

landiolol · β1-adrenergic receptor
Negative in Ames, in vitro mouse lymphoma TK and in vivo rat micronucleus assays

Rasonque

daraxonrasib · RAS(ON) multi-selective
Negative in Ames, in vitro human lymphocyte micronucleus and in vivo mouse micronucleus assays

Recarbrio

imipenem, cilastatin and relebactam · Beta-lactamase (relebactam)
Relebactam negative in Ames, chromosomal aberration and rat bone marrow micronucleus assays

Relyvrio

sodium phenylbutyrate and taurursodiol · ER stress / mitochondrial (proposed)
Negative in Ames, in vitro chromosome aberration (human lymphocytes) and in vivo mouse micronucleus assays

Retevmo

selpercatinib · RET
Negative in Ames and in vitro micronucleus; positive in rat in vivo micronucleus at high doses

Revtorpyk

gedatolisib · PI3K/mTOR
Negative in Ames, human lymphocyte chromosomal aberration and rat bone marrow micronucleus assays

Revuforj

revumenib · Menin-KMT2A
Negative in Ames, in vitro micronucleus and in vivo rat micronucleus assays

Reyvow

lasmiditan · 5-HT1F receptor
Negative in Ames, in vitro chromosome aberration and mouse bone marrow micronucleus assays

Rezdiffra

resmetirom · Thyroid hormone receptor β
Negative in Ames, in vitro chromosome aberration, in vitro micronucleus and in vivo rat micronucleus assays

Rezlidhia

olutasidenib · IDH1 (mutant)
Negative in Ames, in vitro human lymphocyte micronucleus and in vivo rat bone marrow micronucleus assays

Rezurock

belumosudil · ROCK2
Negative in Ames, in vitro chromosomal aberration and rat bone marrow micronucleus assays

Rezzayo

rezafungin · Fungal glucan synthase
Negative in Ames, in vitro mammalian clastogenicity and in vivo rat bone marrow micronucleus assays

Rhapsido

remibrutinib · BTK
Negative in Ames, in vitro human lymphocyte micronucleus and in vivo rat micronucleus assays

Rinvoq

upadacitinib · JAK1
Negative in Ames and in vivo rat micronucleus; in vitro chromosome aberration negative for structural, positive for numerical (polyploidy)

Romvimza

vimseltinib · CSF1R
Negative in vivo rat bone marrow micronucleus and liver DNA strand-break assays; overall negative for genotoxicity

Rozlytrek

entrectinib · TRK/ROS1/ALK
Ames negative; aneugenic in vitro (human lymphocytes); negative in rat micronucleus and comet assays

Rukobia

fostemsavir · HIV-1 gp120 (attachment)
Negative in Ames, human lymphocyte chromosome aberration and rat bone marrow micronucleus assays

Scemblix

asciminib · BCR-ABL1 (STAMP, myristoyl pocket)
Negative in Ames, in vitro human lymphocyte micronucleus and in vivo rat reticulocyte micronucleus assays

Sephience

sepiapterin · Tetrahydrobiopterin precursor
Not genotoxic overall: Ames negative; in vitro chromosome aberration positive without (not with) metabolic activation; rat micronucleus and comet negative

Simtriyo

centanafadine · Triple monoamine reuptake
Negative in Ames, CHO chromosome aberration and rat in vivo micronucleus assays

Skyclarys

omaveloxolone · Nrf2 activator
Negative Ames; positive in vitro chromosomal aberration (human lymphocytes); negative in vivo rat micronucleus and comet assays

Sofdra

sofpironium · Muscarinic receptors (topical)
Negative in Ames, in vitro chromosome aberration and rat micronucleus assays

Sohonos

palovarotene · RARγ
Negative Ames and mouse micronucleus; in vitro chromosomal aberration positive only at cytotoxic concentrations

Sotyktu

deucravacitinib · TYK2
Negative in Ames, in vitro chromosome aberration and in vivo rat micronucleus assays; major metabolites also negative

Sunlenca

lenacapavir · HIV-1 capsid
Negative in Ames, in vitro human lymphocyte chromosome aberration and in vivo rat micronucleus assays

Sunosi

solriamfetol · Dopamine/norepinephrine reuptake
Negative in an adequate battery of genotoxicity assays

Tabrecta

capmatinib · MET
Negative in Ames, in vitro chromosome aberration (human lymphocytes) and rat bone marrow micronucleus assays

Tavneos

avacopan · C5a receptor (C5aR1)
Negative in Ames, mouse lymphoma and in vivo rat bone marrow micronucleus assays

Tazverik

tazemetostat · EZH2
Negative in Ames, in vitro micronucleus (human lymphocytes) and in vivo rat micronucleus assays

Tepmetko

tepotinib · MET
Negative in Ames, in vitro and in vivo micronucleus assays (parent and M506)

Trikafta

elexacaftor, tezacaftor and ivacaftor · CFTR
Elexacaftor negative in bacterial and mammalian in vitro assays and an in vivo chromosomal damage assay

Truqap

capivasertib · AKT1-3
Negative in Ames and mouse lymphoma assays; positive (aneugenic) in rat bone marrow micronucleus; negative liver comet

Truseltiq

infigratinib · FGFR1-3
Negative in Ames, in vitro human lymphocyte chromosome aberration and in vivo rat bone marrow micronucleus assays

Tryptyr

acoltremon · TRPM8 agonist
Negative in Ames, in vitro chromosomal aberration (human lymphocytes) and rat micronucleus assays

Tryvio

aprocitentan · Endothelin A/B receptors
Negative in Ames, in vitro chromosomal aberration and in vivo rat micronucleus assays

Tukysa

tucatinib · HER2
Negative in Ames, in vitro chromosome aberration and mouse bone marrow micronucleus assays

Turalio

pexidartinib · CSF1R
Negative in Ames, in vitro chromosome aberration (human lymphocytes) and rat bone marrow micronucleus assays

Ubrelvy

ubrogepant · CGRP receptor
Negative in Ames, in vitro chromosomal aberration and in vivo rat bone marrow micronucleus assays

Ukoniq

umbralisib · PI3Kδ / CK1ε
Negative in Ames, in vitro TK6 micronucleus and in vivo mouse micronucleus assays

Utebzi

tebipenem pivoxil · Penicillin-binding proteins
Prodrug positive in vitro (mammalian gene mutation, CHO chromosomal aberration); negative in mouse bone marrow micronucleus

Vafseo

vadadustat · HIF prolyl hydroxylase
Ames negative; clastogenic in two in vitro assays; negative in vivo rat comet and chromosome aberration assays; not genotoxic overall

Vanflyta

quizartinib · FLT3
Positive in Ames; negative in mouse lymphoma, human lymphocyte chromosome aberration and rat micronucleus assays

Vanrafia

atrasentan · Endothelin A receptor
Negative in Ames, in vitro chromosomal aberration and in vivo mouse micronucleus assays

Veklury

remdesivir · SARS-CoV-2 RNA polymerase
Negative in Ames, human lymphocyte chromosome aberration and rat micronucleus assays

Velsipity

etrasimod · S1P1/S1P4/S1P5 receptors
Negative in Ames, human lymphocyte chromosomal aberration and rat micronucleus assays

Veozah

fezolinetant · Neurokinin-3 receptor
Negative in Ames, chromosomal aberration and in vivo micronucleus tests

Veppanu

vepdegestrant · Estrogen receptor (PROTAC degrader)
Negative in Ames (parent and ARV-473), in vitro human lymphocyte micronucleus and in vivo rat micronucleus assays

Verquvo

vericiguat · Soluble guanylate cyclase
Negative in Ames, mouse lymphoma and rat and mouse micronucleus assays

Vivjoa

oteseconazole · Fungal CYP51
Negative in Ames, in vitro chromosome aberration and rat micronucleus assays

Vizz

aceclidine · Muscarinic agonist (miotic)
Negative in Ames (Salmonella and E. coli), in vitro chromosome aberration and mouse micronucleus assays

Vonjo

pacritinib · JAK2/FLT3
Negative in Ames, in vitro chromosome aberration (CHO) and in vivo mouse micronucleus assays

Voquezna

vonoprazan · H+/K+-ATPase (potassium-competitive)
Negative in Ames, CHL chromosomal aberration and rat bone marrow micronucleus assays

Voranigo

vorasidenib · IDH1/IDH2
Negative in Ames, in vitro micronucleus, chromosomal aberration and rat bone marrow micronucleus assays (parent and AGI-69460)

Voydeya

danicopan · Complement factor D
Negative in Ames, in vitro human lymphocyte micronucleus and in vivo rat micronucleus assays

Vtama

tapinarof · Aryl hydrocarbon receptor
Negative in Ames, in vitro chromosome aberration, mouse lymphoma and mouse and rat micronucleus assays

Vyndaqel

tafamidis · Transthyretin (stabiliser)
Negative in Ames, in vitro human lymphocyte chromosomal aberration and in vivo rat micronucleus assays

Wakix

pitolisant · Histamine H3 receptor
Negative in Ames, in vitro chromosomal aberration and in vivo mouse micronucleus assays

Wayrilz

rilzabrutinib · BTK (reversible covalent)
Negative in Ames, in vitro human lymphocyte chromosome aberration and rat bone marrow micronucleus assays

Welireg

belzutifan · HIF-2α
Negative in Ames, in vitro human lymphocyte micronucleus and in vivo rat bone marrow micronucleus assays

Winlevi

clascoterone · Androgen receptor (topical)
No clear genotoxic potential; negative Ames and in vitro chromosome aberration assays

Xacduro

sulbactam and durlobactam · PBPs; beta-lactamase (durlobactam)
Durlobactam negative in in vivo rat micronucleus assay up to 2000 mg/kg

Xcopri

cenobamate · Sodium channel / GABA-A
Negative in Ames, mouse lymphoma and rat bone marrow micronucleus assays

Xdemvy

lotilaner · Mite GABA-Cl channel
Negative in Ames, in vitro chromosome aberration (human lymphocytes) and rat micronucleus assays

Xeglyze

abametapir · Lice metalloproteinases
Ames negative (parent and COOH metabolite); chromosome aberrations only at cytotoxic concentrations; rat micronucleus negative

Xenleta

lefamulin · Bacterial ribosome (50S PTC)
Negative in in vivo rat bone marrow micronucleus and in vitro mouse lymphoma assays

Xocova

ensitrelvir · SARS-CoV-2 3CL protease
Negative in Ames, in vitro TK6 micronucleus and in vivo rat micronucleus assays

Xolremdi

mavorixafor · CXCR4
Negative in Ames, in vitro chromosome aberration (human lymphocytes) and rat micronucleus assays

Xpovio

selinexor · XPO1
Negative in Ames, in vitro human lymphocyte cytogenetic and in vivo rat micronucleus assays

Zavzpret

zavegepant · CGRP receptor
Negative in Ames, in vitro CHO chromosomal aberration and in vivo rat micronucleus assays

Zaynich

cefepime and zidebactam · PBPs; beta-lactam enhancer (zidebactam)
Zidebactam negative in mouse lymphoma, human lymphocyte chromosomal aberration and mouse micronucleus assays

Zegfrovy

sunvozertinib · EGFR exon 20 insertion
Negative in Ames, in vitro CHO chromosome aberration and rat bone marrow micronucleus assays

Zenbexus

iberdomide · Cereblon (CELMoD)
In vitro chromosomal aberrations at ≥550 µg/mL; Ames and in vivo assays negative; not considered genotoxic

Zeposia

ozanimod · S1P1/S1P5 receptor
Ozanimod negative (Ames, mouse lymphoma, rat micronucleus); metabolite CC1084037 positive in vitro chromosome aberration, negative in vivo

Zepzelca

lurbinectedin · DNA minor groove (transcription)
Ames negative; positive in mouse lymphoma TK assay; genotoxic

Zevtera

ceftobiprole medocaril · Penicillin-binding proteins
Negative in vivo (micronucleus and rat liver UDS), reducing concern over clastogenic signals in vitro

Zokinvy

lonafarnib · Farnesyltransferase
Negative in Ames, in vitro human lymphocyte chromosomal aberration and mouse micronucleus assays

Ztalmy

ganaxolone · GABA-A receptor (positive modulator)
Negative in Ames, mouse lymphoma and rat micronucleus assays; human metabolite M2 clastogenic in vitro

Zulresso

brexanolone · GABA-A receptor (positive modulator)
Negative in Ames, in vitro human lymphocyte micronucleus and in vivo rat bone marrow micronucleus assays

Zurzuvae

zuranolone · GABA-A receptor (positive modulator)
Negative in Ames, in vitro chromosomal aberration and rat bone marrow micronucleus assays

Zycubo

copper histidinate · Copper replacement (Menkes disease)
Negative in Ames, in vitro TK6 micronucleus and rat bone marrow micronucleus assays

Summary across all 211 small molecules →