GEn-1124 — Competitive Intelligence Brief

GEn-1124 (GEn-1124) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: PI3K inhibitor. Area: Oncology.

phase 2 PI3K inhibitor PI3K Oncology Small molecule

Target snapshot

GEn-1124 (GEn-1124) — GEn1E Lifesciences. GEn-1124 is a small molecule that targets the PI3K/AKT pathway.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
GEn-1124 TARGET	GEn-1124	GEn1E Lifesciences	phase 2	PI3K inhibitor	PI3K
Itovebi	inavolisib	Pfizer	marketed	Kinase Inhibitor [EPC]	phosphatidylinositol 3-kinase (PI3K) alpha (PIK3CA)	2024-01-01
Piqray	alpelisib	Novartis	marketed		PI3Kα	2019-01-01
Placebo followed by Fisetin	Placebo followed by Fisetin	Wake Forest University Health Sciences	marketed	Senolytic agent	Multiple targets including PI3K/Akt and p38 MAPK pathways in senescent cells
Copanlisib (BAY 80-6946)	Copanlisib (BAY 80-6946)	Bayer	phase 3	PI3K inhibitor	PI3K (phosphatidylinositol 3-kinase), pan-class I
GDC 695	GDC 695	Balmoral Medical company	phase 3	PI3K delta inhibitor	PI3K delta (p110δ)
YK-209A tablet	YK-209A tablet	Suzhou Puhe Pharmaceutical Technology Co., LTD	phase 3	PI3K inhibitor	PI3K

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 (PI3K inhibitor class)

1. Addpharma Inc. · 4 drugs in this class
2. AstraZeneca · 3 drugs in this class
3. Bayer · 3 drugs in this class
4. Ahn-Gook Pharmaceuticals Co.,Ltd · 2 drugs in this class
5. InventisBio Co., Ltd · 2 drugs in this class
6. Orient Pharma Co., Ltd. · 2 drugs in this class
7. Applied Biology, Inc. · 1 drug in this class
8. Angitia Incorporated Limited · 1 drug in this class
9. Aevi Genomic Medicine, LLC, a Cerecor company · 1 drug in this class
10. BPGbio · 1 drug in this class