DA-001 — Competitive Intelligence Brief

DA-001 (DA-001) 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

DA-001 (DA-001) — Applied Biology, Inc.. DA-001 is a small molecule that targets the PI3K/AKT pathway.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
DA-001 TARGET	DA-001	Applied Biology, Inc.	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
IPI-145	IPI-145	SecuraBio	phase 3	PI3K delta/gamma inhibitor	PI3K delta (PI3Kδ), PI3K gamma (PI3Kγ)
ONO-4059	ONO-4059	Ono Pharmaceutical Co. Ltd	phase 3	PI3K inhibitor	PI3K (phosphoinositide 3-kinase)

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