Wednesday, July 8, 2026

Drug profile · INN

regorafenib

regorafenib (STIVARGA) is a fibroblast growth factor receptor 2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01EX05
US status approved
Patents linked 1
Pipeline programs 21
News articles 0
Drug details — regorafenib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
1
Programs
21
Data quality
0.84

Quick answer

regorafenib (STIVARGA) is a fibroblast growth factor receptor 2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN regorafenib
Brand STIVARGA
Mechanism Fibroblast growth factor receptor 2 inhibitor
Target Discoidin domain-containing receptor 2
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01EX05

Mechanism of action

Fibroblast growth factor receptor 2 inhibitor

Primary target: Discoidin domain-containing receptor 2

Approval history

Authority Status Date
FDA approved
EMA approved
NMPA clinical trials

Pipeline programs

  1. 20190172 Phase 3 · Amgen · Colorectal Cancer (CRC)
  2. CA224-123 Phase 3 · Bristol-Myers Squibb Australia · Metastatic Colorectal Cancer
  3. MK-4280A-007 Phase 3 · MSD Merck Sharp · Colorectal Cancer
  4. PROICM 2018-01 NEX Phase 3 · George Institute for · Metastatic colorectal cancer
  5. Regorafenib Phase 3 · United Therapeutics Europe · Gastro-Oesophageal Cancer
  6. Regorafenib (BAY73-4506) Phase 3 · Bayer HealthCare Animal · Colorectal Neoplasms
  7. ARC-9 Phase 2 · Arcus Biosciences · Metastatic colorectal cancer
  8. CA043-001 Phase 2 · Bristol-Myers Squibb Australia · Advanced solid tumors (squamous cell carcinoma of the head a

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Related patents

  1. EP 3630112

    KOMBINATION AUS REGORAFENIB UND PD-1/PD-L1(2)-INHIBITOREN ZUR BEHANDLUNG VON KREBS

    Expires Tue Apr 03 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is regorafenib?

regorafenib (STIVARGA) is a fibroblast growth factor receptor 2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for regorafenib?

STIVARGA is a marketed brand name for regorafenib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of regorafenib?

regorafenib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.