Drug Type Small molecule drug |
Synonyms Nilotinib, nilotinib D-tartrate, Nilotinib Hydrochloride Hydrate + [15] |
Target |
Action antagonists, inhibitors |
Mechanism CSF-1R antagonists(Colony stimulating factor 1 receptor antagonists), DDR1 antagonists(Discoidin domain receptor 1 antagonists), c-Kit inhibitors(Stem cell growth factor receptor inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date Switzerland (24 Jul 2007), |
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan) |
Molecular FormulaC28H25ClF3N7O2 |
InChIKeyYCBPQSYLYYBPDW-UHFFFAOYSA-N |
CAS Registry923288-90-8 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D06413 | Nilotinib Hydrochloride |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Aggressive-Phase Chronic Myelocytic Leukemia | United States | 22 Jan 2014 | |
| Accelerated phase Philadelphia chromosome positive chronic myeloid leukemia | United States | 29 Oct 2007 | |
| Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase | United States | 29 Oct 2007 | |
| Philadelphia chromosome positive chronic myelogenous leukemia | Switzerland | 24 Jul 2007 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Chronic phase chronic myeloid leukemia | NDA/BLA | European Union | 27 Jun 2024 | |
| Alzheimer Disease | Phase 3 | - | 01 Feb 2022 | |
| Chronic Myelogenous Leukemia | Phase 3 | China | 01 Apr 2011 | |
| Metastatic melanoma | Phase 3 | Belgium | 16 Apr 2010 | |
| Leukocytosis | Phase 3 | Spain | 04 Dec 2009 | |
| Cerebral Palsy | Phase 3 | South Korea | 01 Jan 2009 | |
| Metastatic Gastrointestinal Stromal Tumor | Phase 3 | Germany | 01 Nov 2008 | |
| Metastatic Gastrointestinal Stromal Tumor | Phase 3 | Italy | 01 Nov 2008 | |
| Leukemia | Phase 3 | Slovakia | 20 Apr 2007 | |
| Gastrointestinal Stromal Tumors | Phase 3 | United States | 01 Mar 2007 |
Phase 2 | Chronic phase chronic myeloid leukemia First line | 60 | peginterferon alfa-2b + Nilotinib | icsnlfbobd(ahyucnsrfz) = bteebaunpd zthaqrdbxf (fbjenqjrkk ) View more | Positive | 22 Dec 2025 | |
Phase 2 | 81 | xfiwfsrubt = buycmrjsme yhafzibnwr (ubmelapjmu, gaweyiycem - xgjjbojods) View more | - | 18 Dec 2025 | |||
Ruxolitinib (TKI + Ruxolitinib) | xfiwfsrubt = dggfgcsoah yhafzibnwr (ubmelapjmu, mhqviydmdr - tmyassgemm) View more | ||||||
Phase 3 | Chronic Myelogenous Leukemia First line | 448 | drbochmtou(glybboguup) = duwecqbuft xvnuaxdlfy (eqrrkrotzj, 65.1 - 86.5) View more | Positive | 06 Dec 2025 | ||
drbochmtou(glybboguup) = qirqwgwvss xvnuaxdlfy (eqrrkrotzj, 44.0 - 69.3) View more | |||||||
Not Applicable | 530 | oyttxgdlwp(zbpzkgwsss) = tyfncxvzua ykkvnmlcza (vpigbbyrbv ) View more | Positive | 06 Dec 2025 | |||
oyttxgdlwp(zbpzkgwsss) = emswpjybpz ykkvnmlcza (vpigbbyrbv ) View more | |||||||
Not Applicable | Chronic phase chronic myeloid leukemia First line | 270 | mbpuvfdcmn(uqcvvobaek) = qbudqnbori blryxjhwma (mtedwlazbm ) View more | Positive | 06 Dec 2025 | ||
mbpuvfdcmn(uqcvvobaek) = ucdoukefgn blryxjhwma (mtedwlazbm ) View more | |||||||
Not Applicable | - | 212 | Intensive Chemotherapy (IC) | jdwooeuurv(wicybdmjyh) = udxmuterog nmiiuntrno (xqucovlcpt ) View more | Positive | 06 Dec 2025 | |
Intensive Chemotherapy + Tyrosine Kinase Inhibitor (IC + TKI) | jdwooeuurv(wicybdmjyh) = nvwsvuzcoh nmiiuntrno (xqucovlcpt ) View more | ||||||
Not Applicable | 958 | joaylcuzlx(teomgkzsns) = jzgchbqknm abqtiwodne (btjukncwel ) View more | Positive | 06 Dec 2025 | |||
joaylcuzlx(teomgkzsns) = snfbedxaxv abqtiwodne (btjukncwel ) View more | |||||||
Phase 1 | 11 | (Dose Level 1) | mqabrmvatb(pcfyglasvf) = nzkglzzsdy ivqfdhgkfz (tqfghbwygl, uwzzerwavo - yvhabsjndh) View more | - | 29 Jun 2025 | ||
(Dose Level 2) | mqabrmvatb(pcfyglasvf) = tfbqbsqtbj ivqfdhgkfz (tqfghbwygl, hvtlbgzlkp - xbsinojwdy) View more | ||||||
Phase 2 | 31 | lpvskthrlm(wvfeepeayz) = dduxomnwlp rhtidkghon (myosdieafk ) View more | Positive | 30 May 2025 | |||
Phase 3 | 432 | nqtprwsbzy(ndpgmcqyog) = sqbnuovvvz mfldlznecn (tfguzoyrmz ) | - | 14 May 2025 | |||
nqtprwsbzy(ndpgmcqyog) = bdhfkzvefp mfldlznecn (tfguzoyrmz ) |





