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gastric bypass

Imperial College London · Phase 1 active Biologic ✓ Verified May 2026

gastric bypass is a Biologic drug developed by Imperial College London. It is currently in Phase 1 development. Also known as: Type 2 diabetes, glucose optimisation, microvascular complications, retinopathy.

Gastric bypass surgery involves dividing the stomach into a small upper pouch and a larger lower "remnant" pouch, then rearranging the small intestine to connect to both. This procedure leads to a marked reduction in the functional volume of the stomach.

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 namegastric bypass
Also known asType 2 diabetes, glucose optimisation, microvascular complications, retinopathy, neuropathy
SponsorImperial College London
ModalityBiologic
PhasePhase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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 gastric bypass

What is gastric bypass?

gastric bypass is a Biologic drug developed by Imperial College London.

Who makes gastric bypass?

gastric bypass is developed by Imperial College London (see full Imperial College London pipeline at /company/imperial-college-london).

Is gastric bypass also known as anything else?

gastric bypass is also known as Type 2 diabetes, glucose optimisation, microvascular complications, retinopathy, neuropathy.

What development phase is gastric bypass in?

gastric bypass is in Phase 1.

Related

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