Nilotinib
Small molecule targets ABL1, CSF1R, DDR1, KIT, PDGFRA via inhibition
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (9) | US (FDA) | TASIGNA | — | 2010-06-17 – 2021-09-23 | fda.gov ↗ |
| Approved | EU (EMA) | Tasigna | — | 2007-11-19 | europa.eu ↗ |
| Approved | US (FDA) | TASIGNA | — | 2007-10-29 | fda.gov ↗ |
Trials 144 · started per year
Also used as a comparator or background therapy in 31 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03228303 Comparator | Dec 2017 → Jul 2020 | chronic myeloid leukemia | Assiut University | Unknown | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT02281474 Comparator | Nov 2014 → May 2015 | Lewy body dementia, Parkinson disease | Georgetown University | Completed | No outcome recorded |
| Phase 1 | NCT02081378 Background | Apr 2014 → Jun 2021 | B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), chronic myeloid leukemia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01751425 Background | Jul 2013 → Sep 2019 | Philadelphia-positive myelogenous leukemia, chronic myeloid leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT01702064 Background | Feb 2013 → Oct 2016 | chronic myeloid leukemia | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT01220648 Background | Apr 2012 → Jan 2014 | chronic myeloid leukemia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04006847 Background | Sep 2020 → May 2021 | chronic myeloid leukemia | Milton S. Hershey Medical Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT02973711 Background | Jan 2018 → Aug 2021 | chronic myeloid leukemia | University of Michigan Rogel Cancer Center | Withdrawn | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT07493408 Background | Mar 2026 → Dec 2035 expected | B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), blast phase chronic myelogenous leukemia, BCR-ABL1 positive, disease related to hematopoietic stem cell transplant | The University of Hong Kong | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04838041 Background | Nov 2021 → Jun 2028 expected | chronic myeloid leukemia | Medical College of Wisconsin | Recruiting | No outcome recorded |
| Phase 2 | NCT04626024 Background | Dec 2020 → Nov 2028 expected | chronic myeloid leukemia | Baylor College of Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04126681 Comparator | Oct 2019 → Aug 2024 | chronic myeloid leukemia | Ascentage Pharma Group Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03906292 Background | Aug 2019 → Dec 2027 expected | chronic myeloid leukemia | University of Jena | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04002674 Comparator | Jul 2019 → Apr 2025 | Lewy body dementia | Georgetown University | Completed | No outcome recorded |
| Phase 2 | NCT03516279 Background | Jun 2019 → Aug 2028 expected | chronic myeloid leukemia | ECOG-ACRIN Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03578367 Comparator | Nov 2018 → Nov 2021 | chronic myeloid leukemia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03654768 Background | Oct 2018 → Jul 2024 overdue | chronic myeloid leukemia | SWOG Cancer Research Network | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03205488 Comparator | Oct 2017 → Aug 2019 | Parkinson disease | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT02954978 Comparator | Jan 2017 → May 2020 | Parkinson disease | Georgetown University | Completed | No outcome recorded |
| Phase 2 | NCT02947893 Comparator | Jan 2017 → Dec 2020 | Alzheimer disease | Georgetown University | Completed | No outcome recorded |
| Phase 2 | NCT01089595 Comparator | Feb 2009 → Nov 2011 | gastrointestinal stromal tumor, metastatic neoplasm | Fox Chase Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT00036738 Background | Jul 2001 → Jul 2014 | B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), adult acute lymphoblastic leukemia, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, childhood acute lymphoblastic leukemia | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT05456191 Comparator | Nov 2022 → May 2025 overdue | Philadelphia-positive myelogenous leukemia | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05143528 Comparator | Feb 2022 → Dec 2025 | Alzheimer disease | KeifeRx, LLC | Unknown | No outcome recorded |
| Phase 3 | NCT04971226 Comparator | Oct 2021 → Nov 2023 overdue | chronic myeloid leukemia | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03079505 Comparator | Aug 2017 → Sep 2018 | chronic myeloid leukemia | Hamad Medical Corporation | Terminated | No outcome recorded |
| Phase 3 | NCT02627677 Comparator | Dec 2015 → Oct 2020 | chronic myeloid leukemia | Ariad Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT02174445 Comparator | Mar 2014 → Dec 2018 | chronic myeloid leukemia | Prof. Dr. Nikolas von Bubnoff | Terminated | No outcome recorded |
| Phase 3 | NCT01657604 Comparator | Aug 2012 → May 2022 | chronic myeloid leukemia | University of Jena | Completed | No outcome recorded |
| Phase 3 | NCT01400074 Comparator | Jan 2009 → Jun 2014 | chronic myeloid leukemia | Seoul St. Mary's Hospital | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04498871 Background | — | hypereosinophilic syndrome | Novartis Pharmaceuticals | No longer available | No outcome recorded |
Press releases naming this drug 10 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-06-14 | Novartis Pharmaceuticals | Novartis continues to innovate in CML with long-term treatment-free remission results following Tasigna® use and promising combination data with investigational compound asciminib (ABL001) novartis.com ↗ |
| 2018-06-02 | Novartis Pharmaceuticals | New Novartis data presented at ASCO find nearly half of CML patients treated with Tasigna® remain in remission almost three years after stopping therapy novartis.com ↗ |
| 2018-03-22 | Novartis Pharmaceuticals | Novartis drug Tasigna® approved by FDA to treat children with rare form of leukemia novartis.com ↗ |
| 2017-12-22 | Novartis Pharmaceuticals | Novartis drug Tasigna® is approved by FDA as first and only CML therapy with Treatment-free Remission data in its label novartis.com ↗ |
| 2017-11-20 | Novartis Pharmaceuticals | Novartis drug Tasigna® (nilotinib) secures EU approval for first and second-line treatment of Ph+ CML-CP in children novartis.com ↗ |
| 2017-06-23 | Novartis Pharmaceuticals | Novartis data shows half of eligible Ph+ CML-CP patients remain in Treatment-free Remission nearly two years after stopping Tasigna® novartis.com ↗ |
| 2017-06-06 | Novartis Pharmaceuticals | Novartis drug Tasigna receives EU approval for inclusion of Treatment-free Remission (TFR) data in product label novartis.com ↗ |
| 2016-12-05 | Novartis Pharmaceuticals | Novartis data shows Treatment-free Remission rates are consistently above 50% regardless of reason for switch to Tasigna® from Glivec® novartis.com ↗ |
| 2016-06-04 | Novartis Pharmaceuticals | Novartis data show more than 50 percent of eligible Ph+ CML patients maintain Treatment-free Remission (TFR) after stopping Tasigna® novartis.com ↗ |
| 2015-06-13 | Novartis Pharmaceuticals | Novartis presents new data from large European study reinforcing the benefit of first-line Tasigna® in newly-diagnosed patients with CML novartis.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 179 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nilotinib | “Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with Philadelphia chromosome-positive chronic myelogenous leukemia...” PMID 17715389 ↗ Aug 2007170“Low dose tyrosine kinase inhibitor (lowTKI) (dasatinib 50 mg daily or imatinib 300 mg daily or nilotinib 300 mg daily) at investigators discretion” NCT05143840 ↗ “Imatinib was given at a dose of 400mg/d or 600mg/d, dasatinib at a dose of 100mg/d or 140mg/d, and nilotinib at a dose of 400mg twice daily.” NCT01883219 ↗ “In this study, the efficacy and safety of nilotinib (AMN107) as a third-line therapy for patients with GISTs was evaluated.” PMID 21456006 ↗ Mar 2011 “Trial Evaluating Nilotinib as Treatment for Newly Diagnosed CML Patients in Accelerated Phase.” NCT01605981 ↗ “The BCR-ABL TKIs that will be used include imatinib, dasatinib, nilotinib or bosutinib.” NCT03610971 ↗ “multiple doses of nilotinib on the pharmacokinetics and metabolism of midazolam” NCT01223898 ↗ “The study drug is nilotinib (Tasigna®).” NCT01261429 ↗ “Mitoxantrone, Nilotinib, Oxaliplatin” NCT02788201 ↗ “Nelarabine Nilotinib Paclitaxel” NCT02551718 ↗ “Nilotinib” NCT01856283 ↗ “Nilotinib” NCT04006847 ↗ “Nilotinib” NCT02142036 ↗ |
| Known as | AMN107 | “Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with Philadelphia chromosome-positive chronic myelogenous leukemia...” PMID 17715389 ↗ Aug 200713“Nilotinib (Tasigna®, code number AMN107) was first approved in 2007 for use in Philadelphia chromosome positive CML in the chronic or accelerated phase in patients resistant or...” NCT01201538 ↗ “A 24 Week, Randomized, Double Blind, Multicenter, Placebocontrolled Efficacy, Safety, Tolerability and PK Trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH)” NCT01179737 ↗ “Nilotinib (Tasigna®, AMN107, Novartis, Switzerland) is approved by U.S. Food and Drug Administration (FDA) and is well tolerated for CML treatment at oral doses of 600-800mg daily.” NCT02954978 ↗ “Preclinical in vitro studies have shown that nilotinib (AMN107), a new BCR-ABL tyrosine kinase inhibitor, is more potent than imatinib against CML cells by a factor of 20 to 50.” PMID 16775235 ↗ Jun 2006 “Imatinib Mesylate (Glivec) as Maintenance Therapy After Cytogenetic Response With Nilotinib (AMN107, Tasigna) First Line in Newly Diagnosed Chronic Myelogenous Leukemia” NCT01316250 ↗ “Nilotinib (Tasigna®, AMN107, Novartis, Switzerland) is approved by the FDA and is well tolerated for CML treatment at oral doses of 600-800mg daily.” NCT04002674 ↗ “An Open-label Phase I/II (Proof of Concept) Trial of an Combination of Nilotinib (AMN 107) and RAD001 in Patients With Acute Myeloid Leukemia” NCT00762632 ↗ “Study of Tasigna®/Nilotinib (AMN107) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas” NCT01275586 ↗ “Drug: Nilotinib (AMN107)” NCT00519090 ↗ “Drug: Nilotinib (AMN107)” NCT00785785 ↗ |
| Known as | Nilotinib (AMN107): Tasigna | “Nilotinib (AMN107): Tasigna” NCT01400074 ↗ |
| Known as | Nilotinib BE | “This study will investigate the safety and efficacy of a Tyrosine Kinase Inhibitor (TKI) called Nilotinib BE (bioequivalent) in individuals with Early Alzheimer's disease (EAD).” NCT05143528 ↗ |
| Known as | Nilotinib Hydrochloride Monohydrate | “Drug: Nilotinib Hydrochloride Monohydrate” NCT05554341 ↗ |
| Known as | Tasigna | “Nilotinib (Tasigna®, code number AMN107) was first approved in 2007 for use in Philadelphia chromosome positive CML in the chronic or accelerated phase in patients resistant or...” NCT01201538 ↗12“We evaluated the efficacy and safety of 1-year treatment with nilotinib (Tasigna®) in patients with autosomal dominant spinocerebellar ataxia (ADSCA) and the factors associated...” PMID 39009709 ↗ Jul 2024 “A 24 Week, Randomized, Double Blind, Multicenter, Placebocontrolled Efficacy, Safety, Tolerability and PK Trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH)” NCT01179737 ↗ “Nilotinib (Tasigna®, AMN107, Novartis, Switzerland) is approved by U.S. Food and Drug Administration (FDA) and is well tolerated for CML treatment at oral doses of 600-800mg daily.” NCT02954978 ↗ “Nilotinib (Tasigna®): orally BID given continuously on Days 1- 28” NCT01887522 ↗ “Nilotinib (Tasigna ®), capsules of 150 mg” NCT03942094 ↗ “Nilotinib (Tasigna ®), capsules of 150 mg” NCT02201459 ↗ “The study drug is nilotinib (Tasigna®).” NCT01261429 ↗ “Nilotinib 150 MG [Tasigna]” NCT03228303 ↗ “Tasigna (nilotinib)” NCT07138378 ↗ “Nilotinib (Tasigna)” NCT01166139 ↗ |
| Known as | XS003 | “XS003 (nilotinib)” NCT07138378 ↗ |
| Action | Inhibit | “potently inhibits activated forms of KIT” PMID 26002753 ↗ May 2015 |
| Modality | Small molecule | “novel aminopyrimidine” NCT00633295 ↗ |
| Route | Oral | “nilotinib PO” NCT00036738 ↗ |
| Target | KIT | “Nilotinib is a tyrosine kinase inhibitor that potently inhibits activated forms of KIT.” PMID 26002753 ↗ May 2015 |