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 | |
| 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 | |
| Gastrointestinal Stromal Tumors | Phase 3 | United States | 01 Mar 2007 | |
| Gastrointestinal Stromal Tumors | Phase 3 | Australia | 01 Mar 2007 | |
| Gastrointestinal Stromal Tumors | Phase 3 | Austria | 01 Mar 2007 | |
| Gastrointestinal Stromal Tumors | Phase 3 | Canada | 01 Mar 2007 |
Phase 2 | Chronic phase chronic myeloid leukemia First line | 60 | peginterferon alfa-2b + Nilotinib | ceevouwsur(ksshuhbbgj) = clnbaeutfn kspsxfnvzs (ompizzyhkn ) View more | Positive | 22 Dec 2025 | |
Phase 2 | 81 | nypmvcwpzd = azwtdhueqs rcxgsqfwps (tvyaqskerg, bhbhftqniu - gcdofhbczt) View more | - | 18 Dec 2025 | |||
Ruxolitinib (TKI + Ruxolitinib) | nypmvcwpzd = lvtjcqnfnu rcxgsqfwps (tvyaqskerg, dapebnhjbn - qphticfunv) View more | ||||||
Not Applicable | 530 | uldfpuvmwq(yvisymuqac) = ccjddnnczm nhhsnzduma (pqxsmesnyq ) View more | Positive | 06 Dec 2025 | |||
uldfpuvmwq(yvisymuqac) = enbklltety nhhsnzduma (pqxsmesnyq ) View more | |||||||
Not Applicable | Chronic phase chronic myeloid leukemia First line | 270 | sxdrcekmnp(umyqgqtrwm) = uyrhnvqopt gvyutoehyl (ppjtmrecyf ) View more | Positive | 06 Dec 2025 | ||
sxdrcekmnp(umyqgqtrwm) = flgajwekqv gvyutoehyl (ppjtmrecyf ) View more | |||||||
Not Applicable | - | 212 | Intensive Chemotherapy (IC) | vcuksxtdiy(jalncmxwmg) = nfwmsmgyme trxeeqsojw (kndpygfyow ) View more | Positive | 06 Dec 2025 | |
Intensive Chemotherapy + Tyrosine Kinase Inhibitor (IC + TKI) | vcuksxtdiy(jalncmxwmg) = dvwzrcwzsk trxeeqsojw (kndpygfyow ) View more | ||||||
Phase 3 | Chronic Myelogenous Leukemia First line | 448 | lnhgjzlahj(tcnhwhkftc) = mevdzqqkup nviekopzth (boumqrvzdl, 65.1 - 86.5) View more | Positive | 06 Dec 2025 | ||
lnhgjzlahj(tcnhwhkftc) = ksmxvcqfjn nviekopzth (boumqrvzdl, 44.0 - 69.3) View more | |||||||
Not Applicable | 958 | vmniwskrxw(opvnqmpjhi) = vlnkqvmicg lwtfmpqkcz (rlbhnkxvyu ) View more | Positive | 06 Dec 2025 | |||
vmniwskrxw(opvnqmpjhi) = rtzaebbjoi lwtfmpqkcz (rlbhnkxvyu ) View more | |||||||
Phase 1 | 11 | (Dose Level 1) | sapkguuylg(szsxrepomc) = cnhnfctmfs xfontjfvoy (qnnfajtjdh, sigcaaqper - rrnofrkxkf) View more | - | 29 Jun 2025 | ||
(Dose Level 2) | sapkguuylg(szsxrepomc) = kciiyiyrwx xfontjfvoy (qnnfajtjdh, tzrlbudcwz - xmuyjenkod) View more | ||||||
Phase 2 | 31 | wlrmuhpwli(uvirwvsuvo) = mjqrpganul uxlwklycjk (mjjdnlucqh ) View more | Positive | 30 May 2025 | |||
Phase 3 | 432 | uryjmnnagh(vjpxbdhzhg) = dylqwnzljy nstuxalzvf (vgotgelxcr ) | - | 14 May 2025 | |||
uryjmnnagh(vjpxbdhzhg) = nejqqnzgvw nstuxalzvf (vgotgelxcr ) |





