Samba Trials' Q2 2026 scan identified 15 industry-sponsored, actively-recruiting gastroenterology trials in Brazil — 2.6% of the country's 582-trial total. The headline number understates the area's strategic weight. IBD specifically sits at the crossroads of three active industry franchises: advanced-mechanism immunology (IL-23, JAK, TL1A, S1P), biosimilar anti-TNF consolidation, and MASH programs where gastroenterology and hepatology overlap. Several of Brazil's largest top-25 sponsors have IBD portfolios that anchor their footprint — AbbVie, Janssen, Eli Lilly, Bristol-Myers Squibb, Takeda, Pfizer, AstraZeneca.
For a biotech with a Phase 2b or Phase 3 IBD asset, the Brazilian consideration is not capacity — it's competing-trial density at the small number of centers that actually enroll IBD patients at pace. Six sites enrolled the vast majority of Brazilian IBD patients in the last multinational advanced-mechanism wave, and most of them are running 3-5 simultaneous biologic or small-molecule IBD protocols at any given time.
Why Brazil for IBD and gastroenterology
- Dedicated academic IBD units. HCPA, the Hospital das Clínicas da FMUSP, UNIFESP, and Hospital Alemão Oswaldo Cruz run IBD-specific ambulatórios with patient registries that predate most clinical-trial-recruitment databases. PIs have 20+ years of biologic-era trial experience.
- SUS access to advanced therapies is rate-limited. This is the honest leverage: SUS provides biologic therapy for IBD but the referral pathway is lengthy and approvals are conservative. That creates a meaningful population of patients who are biologic-naïve or have failed one biologic and cannot rapidly access a second — exactly the population most advanced-mechanism IBD protocols require. Recruitment timelines that take 24 months in the U.S. and Western Europe can often be achieved in 12-15 months in Brazil.
- Endoscopy infrastructure. Central-read endoscopy (SES/UCEIS scoring) is standard at the top IBD sites, with established pipelines to global core labs. Histology central reads are similarly well-established.
- MASH/NASH overlap capacity. Many of the same centers running IBD trials — HCPA especially — also run hepatology protocols. For sponsors with MASH/NASH programs, the PI bench overlaps with IBD enough to make multi-protocol site agreements efficient.
Where the IBD trials run
The IBD map in Brazil is tighter than oncology or cardiology. A well-structured Phase 3 IBD activation will almost always include HCPA, one São Paulo academic site (HC-FMUSP or UNIFESP), one private-academic hybrid (Oswaldo Cruz or Moinhos de Vento), and often one high-volume private-research-center site.
| Center | City / State | Role for IBD / GI trials |
|---|---|---|
| Hospital de Clínicas de Porto Alegre (HCPA) | Porto Alegre, RS | 53 active industry trials; dedicated IBD service with long biologic-era track record. |
| Hospital São Lucas da PUCRS | Porto Alegre, RS | 30 trials; IBD and hepatology research arm; part of the Porto Alegre academic cluster. |
| Hospital Moinhos de Vento | Porto Alegre, RS | 22 trials; private-academic hybrid used for parallel-site activation on multinational IBD programs. |
| Hospital Alemão Oswaldo Cruz | São Paulo, SP | 20 trials; strong IBD PI bench; historical participation in Janssen, AbbVie, Takeda IBD programs. |
| Hospital Sírio-Libanês | São Paulo, SP | 12 trials; gastroenterology and hepatology research unit with private-patient access and central-imaging capacity. |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto (FAMERP) | São José do Rio Preto, SP | 35 trials; high-volume center in SP interior with GI trial capacity. |
Geographically, IBD trials concentrate in São Paulo (state: 252 trials, metro: 454 site-level records), Rio Grande do Sul (189), and Paraná (93). Minas Gerais (75) and the Federal District (48) show up in the longer tail.
Who's sponsoring IBD trials in Brazil
Several of Brazil's top-25 industry sponsors have meaningful IBD portfolios: Janssen Research & Development (28 total active trials), AbbVie (10), Eli Lilly (28), Bristol-Myers Squibb (24), Pfizer (19), AstraZeneca (67), and Takeda (10). Janssen's Stelara / Tremfya franchise, AbbVie's Skyrizi / Rinvoq portfolio, Lilly's mirikizumab, BMS's ozanimod, and Pfizer's etrasimod all run Brazilian arms.
Honest framing: these are total active-trial counts in Brazil across all TAs, not IBD-specific counts. 15 GI trials total means individual sponsor IBD counts are small — typically 1-3 per sponsor. We don't publish sponsor-by-TA granularity in the free data. For TA-specific sponsor rankings see the full quarterly landscape report.
Emerging-biotech opportunity
25% of Brazilian industry trials (148 of 582) come from emerging-biotech sponsors. In IBD specifically, the next wave of advanced-mechanism programs — TL1A, IL-23 subtype-selective, oral S1P, fecal microbiota modulators — is being driven heavily by biotechs that have not yet built a Brazilian site relationship. That's a first-mover window for investigators who have capacity between big-pharma program cohorts.
Regulatory path: IBD-specific considerations
Brazilian regulation runs three parallel tracks: CEP (local), CONEP (central, required for international studies), and ANVISA (the drug-specific clinical-trial dossier). Historical timelines ran 9-12 months end-to-end; under Lei 14.874/2024 the target is ~6 months, with well-run multi-track submissions now activating in 6-8 months.
IBD-specific considerations:
- Endoscopy image export. Central-read endoscopy to a global core lab is a de-facto requirement for modern IBD Phase 3 trials. Brazilian sites have pipelines for this, but CONEP will scrutinize image-data-transfer clauses in the protocol. Address patient-image handling explicitly in the ICF.
- Biosample (serum, stool microbiome, histology) export. Most modern IBD protocols include biomarker arms with biological-material export. Requires formal Termo de Transferência de Material Biológico and CONEP clearance from day one.
- Prior-biologic washout documentation. Because SUS-access records for biologics are not fully digitized, expect CRO site-monitoring burden to be higher than in comparable European geographies for verifying prior-therapy lines. Budget accordingly.
How Samba Trials helps
Samba Trials is the clinical-trials consultancy arm of BioAlma. For IBD sponsors specifically, site competition at the small number of high-enrolling centers is the dominant feasibility risk — not regulatory timelines. We help sponsors see it in advance.
- TA-specific feasibility memos. A 2-3 week review of your IBD protocol against Brazilian site capacity, competing-mechanism trial overlap (critical for IBD where multiple IL-23, JAK, S1P programs queue at the same 6-8 centers), SUS biologic-access landscape for the target subpopulation, and realistic enrollment-timeline ranges.
- Site identification and activation support. Named-center shortlists with PI profiles, active-trial load, historical IBD-sponsor relationships, and endoscopy/histology central-read capacity.
- ANVISA submission strategy. Parallel-track planning for CEP/CONEP/ANVISA, dossier review, and biospecimen-export strategy covering endoscopy imaging, histology, serum, and microbiome samples.
Get an IBD feasibility memo
Send us your protocol synopsis or target indication. We'll return a Brazil-specific feasibility memo within two weeks — named centers, competing-trial overlap, PI candidates, and enrollment ranges.
Request a memo →