IV Arsenic Trioxide — Competitive Intelligence Brief

IV Arsenic Trioxide (IV Arsenic Trioxide) competitive landscape: 2 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Arsenic compound; differentiation agent and apoptosis inducer. Area: Oncology.

phase 3 Arsenic compound; differentiation agent and apoptosis inducer PML-RARA fusion protein; mitochondrial apoptotic pathway Oncology Small molecule

Target snapshot

IV Arsenic Trioxide (IV Arsenic Trioxide) — SDK Therapeutics, Inc.. Arsenic trioxide induces differentiation and apoptosis of leukemic cells, particularly in acute promyelocytic leukemia, through multiple pathways including PML-RARA degradation and reactive oxygen species generation.

Comparator set (2 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
IV Arsenic Trioxide TARGET	IV Arsenic Trioxide	SDK Therapeutics, Inc.	phase 3	Arsenic compound; differentiation agent and apoptosis inducer	PML-RARA fusion protein; mitochondrial apoptotic pathway
ATO	ATO	South China Children's Leukemia Group	marketed	Arsenic compound; differentiation agent	PML-RARA fusion protein; mitochondrial apoptotic pathways
Ibrutinib combined with As2O3	Ibrutinib combined with As2O3	Peking University People's Hospital	phase 3	BTK inhibitor combined with arsenic compound	BTK (Bruton's tyrosine kinase); As2O3 has multiple targets including PML-RARA fusion protein and mitochondrial pathways

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Arsenic compound; differentiation agent and apoptosis inducer class)

1. Medsenic · 1 drug in this class
2. SDK Therapeutics, Inc. · 1 drug in this class