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SGI-110 Dose Escalation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 1 active Small molecule ✓ Verified May 2026 Quality 20/100

SGI-110 Dose Escalation is a Small molecule drug developed by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. It is currently in Phase 1 development. Also known as: Guadecitabine.

SGI-110 is a small molecule being studied in combination with carboplatin in a Phase 2 trial for platinum-resistant recurrent ovarian cancer. The trial also involves dose escalation of SGI-110 in combination with various treatments, including topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine, for other cancer types such as ovarian cancer, small cell lung cancer, melanoma, non small cell lung cancer, and colorectal adenocarcinoma.

Likelihood of approval
9.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2033–2036 —
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +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 nameSGI-110 Dose Escalation
Also known asGuadecitabine
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ModalitySmall molecule
PhasePhase 1

Approved indications

No approved indications tracked.

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 SGI-110 Dose Escalation

What is SGI-110 Dose Escalation?

SGI-110 Dose Escalation is a Small molecule drug developed by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Who makes SGI-110 Dose Escalation?

SGI-110 Dose Escalation is developed by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (see full Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins pipeline at /company/sidney-kimmel-comprehensive-cancer-center-at-johns-hopkins).

Is SGI-110 Dose Escalation also known as anything else?

SGI-110 Dose Escalation is also known as Guadecitabine.

What development phase is SGI-110 Dose Escalation in?

SGI-110 Dose Escalation is in Phase 1.

What are the side effects of SGI-110 Dose Escalation?

Common side effects of SGI-110 Dose Escalation include Neutropenia, Leukopenia, Lymphopenia, Nausea, Anemia, Fever.

Related

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