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Streptozotocin

Hoffmann-La Roche · Phase 3 active Small molecule Under review

Streptozotocin is a Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for Pancreatic Neuroendocrine Tumor.

Streptozotocin is a small molecule DNA inhibitor used as an alkylating antineoplastic agent. It is particularly toxic to the insulin-producing beta cells of the pancreas and is used in medicine to treat certain cancers, including those of the islets of Langerhans, and conditions such as Zollinger-Ellison Syndrome.

Likelihood of approval
64.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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.
  • Big-pharma sponsor +3.0pp
    Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameStreptozotocin
SponsorHoffmann-La Roche
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

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 Streptozotocin

What is Streptozotocin?

Streptozotocin is a Small molecule drug developed by Hoffmann-La Roche, indicated for Pancreatic Neuroendocrine Tumor.

What is Streptozotocin used for?

Streptozotocin is indicated for Pancreatic Neuroendocrine Tumor.

Who makes Streptozotocin?

Streptozotocin is developed by Hoffmann-La Roche (see full Hoffmann-La Roche pipeline at /company/roche).

What development phase is Streptozotocin in?

Streptozotocin is in Phase 3.

What are the side effects of Streptozotocin?

Common side effects of Streptozotocin include Nausea, Vomiting, Diarrhea, Hepatic toxicity, Hematological toxicity, Mild to moderate abnormalities of glucose tolerance.

Related

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