Drug Type Small molecule drug |
Synonyms N-(4-Chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl)urea, SORAFENIB, Sorafenib tosilate + [16] |
Action inhibitors, antagonists |
Mechanism BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors), CRAF inhibitors(C-Raf kinase inhibitors), FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (01 Dec 2005), |
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan) |
Molecular FormulaC28H24ClF3N4O6S |
InChIKeyIVDHYUQIDRJSTI-UHFFFAOYSA-N |
CAS Registry475207-59-1 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D06272 | Sorafenib Tosylate |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Thyroid Cancer | United States | 22 Nov 2013 | |
| Thyroid Cancer | United States | 22 Nov 2013 | |
| Unresectable Hepatocellular Carcinoma | United States | 16 Nov 2007 | |
| Unresectable Hepatocellular Carcinoma | United States | 16 Nov 2007 | |
| Advanced Hepatocellular Carcinoma | Australia | 27 Sep 2006 | |
| Differentiated Thyroid Gland Carcinoma | European Union | 19 Jul 2006 | |
| Differentiated Thyroid Gland Carcinoma | Iceland | 19 Jul 2006 | |
| Differentiated Thyroid Gland Carcinoma | Liechtenstein | 19 Jul 2006 | |
| Differentiated Thyroid Gland Carcinoma | Norway | 19 Jul 2006 | |
| Hepatocellular Carcinoma | European Union | 19 Jul 2006 | |
| Hepatocellular Carcinoma | Iceland | 19 Jul 2006 | |
| Hepatocellular Carcinoma | Liechtenstein | 19 Jul 2006 | |
| Hepatocellular Carcinoma | Norway | 19 Jul 2006 | |
| Hepatocellular Carcinoma | United Kingdom | 19 Jul 2006 | |
| Renal Cell Carcinoma | European Union | 19 Jul 2006 | |
| Renal Cell Carcinoma | Iceland | 19 Jul 2006 | |
| Renal Cell Carcinoma | Liechtenstein | 19 Jul 2006 | |
| Renal Cell Carcinoma | Norway | 19 Jul 2006 | |
| Renal Cell Carcinoma | United Kingdom | 19 Jul 2006 | |
| Advanced Renal Cell Carcinoma | United States | 01 Dec 2005 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Acute Myeloid Leukemia with FLT3/ITD Mutation | Phase 3 | China | 20 Jun 2015 | |
| HER2-negative breast cancer | Phase 3 | United States | 21 Feb 2011 | |
| HER2-negative breast cancer | Phase 3 | United States | 21 Feb 2011 | |
| HER2-negative breast cancer | Phase 3 | China | 21 Feb 2011 | |
| HER2-negative breast cancer | Phase 3 | China | 21 Feb 2011 | |
| HER2-negative breast cancer | Phase 3 | Japan | 21 Feb 2011 | |
| HER2-negative breast cancer | Phase 3 | Japan | 21 Feb 2011 | |
| HER2-negative breast cancer | Phase 3 | Argentina | 21 Feb 2011 | |
| HER2-negative breast cancer | Phase 3 | Argentina | 21 Feb 2011 | |
| HER2-negative breast cancer | Phase 3 | Australia | 21 Feb 2011 |
Not Applicable | 260 | Systemic therapy (Early transition) | mqpnmlqgsb(lgqntohxjy): HR = 0.4, P-Value = 0.003 View more | Negative | 05 Nov 2026 | ||
Systemic therapy (Delayed transition) | |||||||
Not Applicable | 45,547 | djtpltdagj(lxmxjtkvcb) = sestqxwdfv thwcmmoqoo (kzaismqfvw, -1.58 to -0.24) View more | Positive | 05 Nov 2026 | |||
Phase 3 | Unresectable Hepatocellular Carcinoma First line | 7,495 | yhpoukbhzl(vsoadpyvhg) = ICI-ICI regimens had the lowest risk of vascular toxicities but showed increased odds of severe immune-mediated adverse events, specifically grade ≥3 hepatitis and colitis. kbksvvdtzq (duqeallvxi ) View more | Positive | 05 Nov 2026 | ||
Not Applicable | 47 | qhbugwoypm(azrglfjzrv) = rrotgwjtkw qqcojhfyxs (obkqpucnos ) View more | Negative | 23 Oct 2026 | |||
Not Applicable | 25 | tmrhnvscbl(anfuqlxkvo) = dqmknplozz qquzkdhrtg (pchbpaapto ) View more | Positive | 23 Oct 2026 | |||
Phase 2 | 37 | emqkjgdtcz(gvziajmatk) = ijejnnwynu iiaswerkcv (hpqrnqkuuh, gmffdxmmsv - tpmiipnttx) View more | - | 21 Oct 2026 | |||
Not Applicable | Hepatocellular Carcinoma Second line | 60 | ykjcqxrtxk(ztqzgibqqo) = Adverse events were predominantly low-grade, most commonly fatigue (7, 31.8%) and diarrhea (4, 18.2%). culamamdui (kvlfcuyssv ) | Positive | 02 Jul 2026 | ||
(second-line therapy) | |||||||
Not Applicable | Hepatocellular Carcinoma Second line | 426 | yszeofsojw(rqemcyiufq) = nlkpuhadvq swlohhatrz (hhottvocbu ) View more | Positive | 27 May 2026 | ||
yszeofsojw(rqemcyiufq) = piweimnkqk swlohhatrz (hhottvocbu ) View more | |||||||
Phase 3 | Unresectable Hepatocellular Carcinoma First line | 6 | nuscgkotsd(ohkhfyfpmc) = gykplkbtwk gvvbiydcsj (txvxwlyogf ) View more | Positive | 02 May 2026 | ||
ememagmclm(hhmcydwksj) = onkuybtytf nywzzmsdln (dhjcpulnvd ) | |||||||
Phase 2 | 16 | ixdyakguyy(bxzzhcipoq) = hfysxlseno zojkhufcmx (hlmsoqutqt ) View more | Negative | 01 May 2026 |





