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Aldoxorubicin HCl
Aldoxorubicin HCl is a antitumor antibiotic Small molecule drug developed by ImmunityBio, Inc.. It is currently in Phase 2 development for Solid tumors.
Aldoxorubicin HCl is a prodrug that selectively releases doxorubicin in acidic environments, such as tumor cells, to exert its cytotoxic effects.
Aldoxorubicin HCl is a prodrug that selectively releases doxorubicin in acidic environments, such as tumor cells, to exert its cytotoxic effects. Used for Solid tumors.
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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). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| 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 | Aldoxorubicin HCl |
|---|---|
| Sponsor | ImmunityBio, Inc. |
| Drug class | antitumor antibiotic |
| Target | DNA topoisomerase II |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
The selective release of doxorubicin from Aldoxorubicin HCl occurs in the acidic lysosomes of cancer cells, leading to DNA damage and apoptosis. This mechanism aims to reduce systemic toxicity associated with conventional doxorubicin administration.
Approved indications
- Solid tumors
Common side effects
- Neutropenia
- Anemia
- Thrombocytopenia
Key clinical trials
- Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer (PHASE2)
- QUILT-3.091 NANT Chordoma Vaccine vs Radiation in Subjects With Unresectable Chordoma. (PHASE1, PHASE2)
- QUILT-3.088: NANT Pancreatic Cancer Vaccine (PHASE2)
- QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine (PHASE2)
- QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine (PHASE1, PHASE2)
- QUILT-3.080: NANT Pancreatic Cancer Vaccine (PHASE1, PHASE2)
- QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy. (PHASE1, PHASE2)
- QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed (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:
- Aldoxorubicin HCl CI brief — competitive landscape report
- Aldoxorubicin HCl updates RSS · CI watch RSS
- ImmunityBio, Inc. portfolio CI
Frequently asked questions about Aldoxorubicin HCl
What is Aldoxorubicin HCl?
How does Aldoxorubicin HCl work?
What is Aldoxorubicin HCl used for?
Who makes Aldoxorubicin HCl?
What drug class is Aldoxorubicin HCl in?
What development phase is Aldoxorubicin HCl in?
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What does Aldoxorubicin HCl target?
Related
- Drug class: All antitumor antibiotic drugs
- Target: All drugs targeting DNA topoisomerase II
- Manufacturer: ImmunityBio, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Solid tumors
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing