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IA regimen
IA regimen is a Chemotherapy combination (alkylating agent + anthracycline) Small molecule drug developed by The First Affiliated Hospital of Soochow University. It is currently in Phase 3 development for Soft tissue sarcoma, Osteosarcoma, Other solid tumors (investigational).
IA regimen is a chemotherapy combination that uses ifosfamide and doxorubicin to damage cancer cell DNA and inhibit cell division.
BC3195 is a small molecule being studied in a Phase Ia/Ib clinical trial for its safety, pharmacokinetics, and antitumor activity in patients with advanced or metastatic cancer. The trial involves dose escalation and expansion of BC3195 in combination with other treatments, including CACAG+VEN and 3+7, for various cancer types.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | IA regimen |
|---|---|
| Sponsor | The First Affiliated Hospital of Soochow University |
| Drug class | Chemotherapy combination (alkylating agent + anthracycline) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
The IA regimen combines ifosfamide, an alkylating agent that cross-links DNA strands, with doxorubicin, a topoisomerase II inhibitor and intercalating agent. Together, these agents create multiple forms of DNA damage that overwhelm cancer cell repair mechanisms and trigger apoptosis. This combination is commonly used in sarcoma and other solid tumors.
Approved indications
- Soft tissue sarcoma
- Osteosarcoma
- Other solid tumors (investigational)
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia)
- Nausea and vomiting
- Alopecia
- Cardiotoxicity (doxorubicin-related)
- Hemorrhagic cystitis (ifosfamide-related)
Key clinical trials
- Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML (PHASE3)
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients (PHASE2)
- Study of Long-Term Safety and Efficacy on Gene Therapy in Glycogen Storage Disease Type Ia
- Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer (NA)
- Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients (PHASE3)
- S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer (PHASE3)
- A Study of CSCJC3456 in Patients With Advanced Malignant Tumors (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:
- IA regimen CI brief — competitive landscape report
- IA regimen updates RSS · CI watch RSS
- The First Affiliated Hospital of Soochow University portfolio CI
Frequently asked questions about IA regimen
What is IA regimen?
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Related
- Drug class: All Chemotherapy combination (alkylating agent + anthracycline) drugs
- Manufacturer: The First Affiliated Hospital of Soochow University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Soft tissue sarcoma
- Indication: Drugs for Osteosarcoma
- Indication: Drugs for Other solid tumors (investigational)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing