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Nilotinib-adriamycin
Nilotinib-adriamycin is a Small molecule drug developed by Broto, Javier Martín, M.D.. It is currently in Phase 1 development. Also known as: Nilotinib Tasigna, Doxorubicin hydrochloride.
Nilotinib is a small molecule used in combination with chemotherapy, including adriamycin, to treat various blood cancers such as Philadelphia chromosome-positive adult precursor acute lymphoblastic leukemia. The combination of nilotinib with chemotherapy, including cyclophosphamide and rituximab, has been studied in clinical trials for the treatment of these conditions.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Nilotinib-adriamycin |
|---|---|
| Also known as | Nilotinib Tasigna, Doxorubicin hydrochloride |
| Sponsor | Broto, Javier Martín, M.D. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Anemia
- Fatigue
- Generalized muscle weakness
- Infections and infestations - Other, Bacteremia
- Neutrophil count decreased
- Platelet count decreased
- White blood cell decreased
- Febrile Neutropenia
- Dysgeusia
- Gastrointestinal disorders - Other, Hernia
- Hyponatremia
- Thromboembolic event
Key clinical trials
- Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma (PHASE2)
- Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia (PHASE2)
- Trial of Nilotinib and Adriamycin as Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nilotinib-adriamycin CI brief — competitive landscape report
- Nilotinib-adriamycin updates RSS · CI watch RSS
- Broto, Javier Martín, M.D. portfolio CI
Frequently asked questions about Nilotinib-adriamycin
What is Nilotinib-adriamycin?
Who makes Nilotinib-adriamycin?
Is Nilotinib-adriamycin also known as anything else?
What development phase is Nilotinib-adriamycin in?
What are the side effects of Nilotinib-adriamycin?
Related
- Manufacturer: Broto, Javier Martín, M.D. — full pipeline
- Also known as: Nilotinib Tasigna, Doxorubicin hydrochloride
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing