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gastric bypass
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.
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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).
| 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 name | gastric bypass |
|---|---|
| Also known as | Type 2 diabetes, glucose optimisation, microvascular complications, retinopathy, neuropathy |
| Sponsor | Imperial College London |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass (NA)
- The FundoRingOAGB Versus Non-wrapping (Non-banded) Standard Method of Laparoscopic One Anastomosis Gastric Bypass (NA)
- FundoRing Roux-en-Y Gastric Bypass Versus FundoRing One Anastomosis Gastric Bypass (NA)
- Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study) (NA)
- Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study (PHASE1, PHASE2)
- OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers (PHASE4)
- Linear vs. Circular Stapled Gastrojejunal Anastomosis in Bariatric Laparoscopic Gastric Bypass Surgery in Switzerland
- Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study (NA)
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:
- gastric bypass CI brief — competitive landscape report
- gastric bypass updates RSS · CI watch RSS
- Imperial College London portfolio CI
Frequently asked questions about gastric bypass
What is gastric bypass?
Who makes gastric bypass?
Is gastric bypass also known as anything else?
What development phase is gastric bypass in?
Related
- Manufacturer: Imperial College London — full pipeline
- Also known as: Type 2 diabetes, glucose optimisation, microvascular complications, retinopathy, neuropathy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing