Stivarga — Competitive Intelligence Brief

Stivarga (regorafenib) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Kinase Inhibitor. Area: Oncology.

marketed Kinase Inhibitor Bifunctional epoxide hydrolase 2 Oncology

Target snapshot

Stivarga (regorafenib) — Bayer. Stivarga blocks the activity of enzymes involved in tumor growth and angiogenesis.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Stivarga TARGET	regorafenib	Bayer	marketed	Kinase Inhibitor	Bifunctional epoxide hydrolase 2	2012-01-01
Faslodex	Faslodex	Translational Oncology Research International	marketed		NAD-dependent protein deacylase sirtuin-5, mitochondrial, Bifunctional epoxide hydrolase 2, G-protein coupled estrogen receptor 1
Hernexeos	ZONGERTINIB	Boehringer Ingelheim	marketed	Kinase Inhibitor [EPC]		2025-01-01
Itovebi	INAVOLISIB	Genentech Inc	marketed	Kinase Inhibitor [EPC]		2025-01-01
Wayrilz	RILZABRUTINIB	Genzyme Corp	marketed	Kinase Inhibitor [EPC]		2025-01-01
Romvimza	VIMSELTINIB	Deciphera Pharms	marketed	Kinase Inhibitor [EPC]		2025-01-01
Ojemda	TOVORAFENIB	Day One Biopharms	marketed	Kinase Inhibitor [EPC]		2024-01-01

Recent regulatory actions (last 90 days)

• 2026-02-26 — Hernexeos · FDA · approved · US · Boehringer Ingelheim

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 (Kinase Inhibitor class)

1. Novartis · 5 drugs in this class
2. Pfizer · 3 drugs in this class
3. Bayer · 2 drugs in this class
4. Boehringer Ingelheim · 2 drugs in this class
5. Hoffmann-La Roche · 1 drug in this class
6. Exelixis Inc · 1 drug in this class
7. Novartis Pharm · 1 drug in this class
8. Osi Pharms · 1 drug in this class
9. Exelixis · 1 drug in this class
10. Roche · 1 drug in this class