Last reviewed · How we verify

Isophosphamide

Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 2 active Small molecule Under review

Isophosphamide is a Small molecule drug developed by Second Affiliated Hospital, School of Medicine, Zhejiang University. It is currently in Phase 2 development for Testicular Germ Cell Tumor. Also known as: ifosfamide, Ifex.

Isophosphamide is a chemotherapy medication used to treat various types of cancer, including adult and childhood soft tissue sarcoma, as well as other cancers such as testicular cancer, bladder cancer, and ovarian cancer. It is classified as a cross-linking agent that works by forming DNA cross-links, and is administered by injection into a vein.

Likelihood of approval
13.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameIsophosphamide
Also known asifosfamide, Ifex
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 2

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Isophosphamide

What is Isophosphamide?

Isophosphamide is a Small molecule drug developed by Second Affiliated Hospital, School of Medicine, Zhejiang University, indicated for Testicular Germ Cell Tumor.

What is Isophosphamide used for?

Isophosphamide is indicated for Testicular Germ Cell Tumor.

Who makes Isophosphamide?

Isophosphamide is developed by Second Affiliated Hospital, School of Medicine, Zhejiang University (see full Second Affiliated Hospital, School of Medicine, Zhejiang University pipeline at /company/second-affiliated-hospital-school-of-medicine-zhejiang-university).

Is Isophosphamide also known as anything else?

Isophosphamide is also known as ifosfamide, Ifex.

What development phase is Isophosphamide in?

Isophosphamide is in Phase 2.

What are the side effects of Isophosphamide?

Common side effects of Isophosphamide include Nausea/Vomiting, Leukopenia, Anemia, Infection, Central nervous system toxicity, Alopecia.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing