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Nadunolimab
Nadunolimab is a Small molecule drug developed by M.D. Anderson Cancer Center. It is currently in Phase 2 development. Also known as: CAN04.
Nadunolimab is an antibody being studied in clinical trials for various conditions, including Myelodysplastic Syndrome, Acute Myelogenous Leukemia, and other types of cancer. It is being investigated in combination with other treatments, such as Azacitidine and Venetoclax, in a Phase 1B/2A trial.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Nadunolimab |
|---|---|
| Also known as | CAN04 |
| Sponsor | M.D. Anderson Cancer Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Immunoprevention for High-risk Lung Lesions (PHASE2)
- A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML) (PHASE1, PHASE2)
- Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC (PHASE1, PHASE2)
- Nadunolimab in Combination with Gemcitabine Plus Carboplatin in Patients with Advanced Triple Negative Breast Cancer. (PHASE1, PHASE2)
- A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors (PHASE1, PHASE2)
- A Study of the Safety and Tolerance of CAN04 in Combination With FOLFIRINOX in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma (PHASE1)
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:
- Nadunolimab CI brief — competitive landscape report
- Nadunolimab updates RSS · CI watch RSS
- M.D. Anderson Cancer Center portfolio CI
Frequently asked questions about Nadunolimab
What is Nadunolimab?
Who makes Nadunolimab?
Is Nadunolimab also known as anything else?
What development phase is Nadunolimab in?
Related
- Manufacturer: M.D. Anderson Cancer Center — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: CAN04
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing