Independent industry tracker · 2023–2026 · Last updated July 2026.
A public-data snapshot from ClinicalTrials.gov showing how much industry-sponsored early-phase activity — from Big Pharma to venture-backed device startups — already runs at Latin American sites. These are independent, publicly reported programs — a snapshot of how active the region already is.
Industry-sponsored Phase 1 / early-phase interventional trials with a Latin American site, started on or after January 1, 2023. Source: ClinicalTrials.gov, retrieved July 2026.
Figures are ClinicalTrials.gov registry data only (industry-sponsored, interventional, Phase 1 / Early Phase 1, ≥1 Latin American site, started on/after Jan 1 2023). Press-release-sourced device programs listed below are not included in these counts.
| Company (sponsor of record) | Program / intervention | Area | Type | Phase | Site(s) registered in | Started | Status (per source, Jul 2026) | Source |
|---|---|---|---|---|---|---|---|---|
| Pfizer | Disitamab vedotin | Oncology (HER2+ breast) | Drug / Biologic | Phase 1/2 | Brazil | 2025 | Recruiting | NCT06966453 |
| GSK | GSK4527363 (first-time-in-human) | Immunology (lupus) | Drug / Biologic | Phase 1 | Brazil, Argentina | 2024 | Recruiting | NCT06576271 |
| AstraZeneca | Rilvegostomig combinations | Oncology (NSCLC) | Drug / Biologic | Phase 1/2 | Brazil | 2025 | Recruiting | NCT06996782 |
| Merck (MSD) | Zilovertamab vedotin | Oncology (pediatric) | Drug / Biologic | Phase 1/2 | Brazil, Colombia | 2024 | Recruiting | NCT06395103 |
| Roche / Genentech | Divarasib | Oncology (KRAS G12C NSCLC) | Drug / Biologic | Phase 1/2 | Brazil, Argentina | 2023 | Recruiting | NCT05789082 |
| Hoffmann-La Roche | RO7507062 (first-in-human) | Immunology (lupus) | Drug / Biologic | Phase 1 | Chile, Colombia | 2023 | Active | NCT05835986 |
| Novartis | PIT565 | Immunology (rheumatoid arthritis) | Drug / Biologic | Phase 1 | Argentina | 2025 | Active | NCT07029555 |
| Sanofi | SAR444836 (AAV gene therapy) | Rare disease (PKU) | Drug / Biologic | Phase 1/2 | Brazil | 2023 | Active | NCT05972629 |
| Amgen | Anvumetostat | Oncology (thoracic) | Drug / Biologic | Phase 1 | Brazil, Argentina | 2024 | Active | NCT06333951 |
| Boehringer Ingelheim | BI 770371 | Oncology (head & neck SCC) | Drug / Biologic | Phase 1 | Brazil | 2025 | Active | NCT06806852 |
| Daiichi Sankyo | Valemetostat tosylate | Oncology (NSCLC) | Drug / Biologic | Phase 1/2 | Brazil, Argentina | 2024 | Recruiting | NCT06644768 |
| Bristol-Myers Squibb | BMS-986458 | Oncology (non-Hodgkin lymphoma) | Drug / Biologic | Phase 1/2 | Chile | 2023 | Recruiting | NCT06090539 |
| Bayer | Acetylsalicylic acid (pharmacokinetics) | Clinical pharmacology | Drug / Biologic | Phase 1 | Mexico | 2025 | Completed | NCT06655194 |
| Servier | S095018 / S095024 / S095029 | Oncology (NSCLC) | Drug / Biologic | Phase 1/2 | Brazil, Argentina | 2024 | Active | NCT06162572 |
| BeOne Medicines (BeiGene) | BGB-B2033 | Oncology (solid tumors) | Drug / Biologic | Phase 1 | Brazil | 2024 | Recruiting | NCT06427941 |
| ADC Therapeutics | Loncastuximab tesirine | Oncology (DLBCL) | Drug / Biologic | Phase 1 | Brazil | 2023 | Recruiting | NCT05660395 |
| GC Biopharma | HM15421 / GC1134A | Rare disease (Fabry) | Drug / Biologic | Phase 1/2 | Argentina | 2025 | Recruiting | NCT06858397 |
| Windtree Therapeutics | Istaroxime | Cardiology (cardiogenic shock) | Drug / Biologic | Phase 1/2 | Argentina | 2024 | Active | NCT05975021 |
| Sandoz | GME751 (pembrolizumab biosimilar) | Oncology (melanoma) | Drug / Biologic | Phase 1 | Brazil | 2024 | Completed | NCT06153238 |
| Praxis Precision Medicines | PRAX-222 | Neurology (pediatric epilepsy) | Drug / Biologic | Phase 1/2 | Brazil | 2023 | Recruiting | NCT05737784 |
| Spur Therapeutics | FLT201 (AAV gene therapy) | Rare disease (Gaucher) | Drug / Biologic | Phase 1/2 | Brazil | 2024 | Active | NCT06545136 |
| Vega Therapeutics | VGA039 | Hematology (von Willebrand disease) | Drug / Biologic | Phase 1/2 | Brazil | 2023 | Recruiting | NCT05776069 |
| BridgeBio Oncology (BBOT) | BBO-10203 | Oncology (solid tumors) | Drug / Biologic | Phase 1 | Brazil | 2024 | Recruiting | NCT06625775 |
| Gemma Biotherapeutics | GB221 | Rare disease (SMA type 1) | Drug / Biologic | Phase 1/2 | Brazil | 2026 | Recruiting | NCT07070999 |
| Unravel Biosciences | Vorinostat (repurposed) | Neurology (Rett syndrome) | Drug / Biologic | Phase 1 | Colombia | 2026 | Recruiting | NCT07150013 |
| Knight Therapeutics | Pomalidomide (bioequivalence) | Clinical pharmacology | Drug / Biologic | Phase 1 | Chile | 2025 | Completed | NCT07694011 |
| XCath | Iris endovascular robot (telerobotic thrombectomy) | Neurovascular / stroke | Device / Robotics | First-in-human | Panama | 2026 | FIH completed | FierceBiotech |
| SonoVascular | SonoThrombectomy System | Vascular (deep vein thrombosis) | Device / Robotics | First-in-human | Chile | 2024 | FIH completed | PR Newswire |
| Nyra Medical | CARLEN System (ENHANCE EFS) | Structural heart (mitral regurgitation) | Device / Robotics | Early feasibility | Brazil | 2026 | Enrolling | NCT07503236 |
| Supira Medical | Supira System (percutaneous VAD) | Cardiology (high-risk PCI support) | Device / Robotics | Early feasibility / FIH | Paraguay | 2023 | Active | NCT05864248 |
| ReValve Solutions | ReValve System | Structural heart (mitral replacement) | Device / Robotics | Early feasibility | Brazil | 2026 | Recruiting | NCT07601269 |
| Nervonik | Peripheral nerve stimulation device | Neuromodulation | Device / Robotics | Early feasibility | Panama | 2024 | Recruiting | NCT06772142 |
| Capstan Medical | Robotic transcatheter mitral valve replacement | Structural heart / robotics | Device / Robotics | First-in-human | Chile | 2025 | FIH completed | MassDevice |
| Protaryx Medical | Transseptal puncture device | Structural heart access | Device / Robotics | First-in-human | Paraguay | 2024 | FIH completed | Protaryx |
| Avvio Medical | Kidney-stone treatment device | Urology | Device / Robotics | First-in-human | Paraguay | 2025 | FIH completed | |
| InterVene | Recana Thrombectomy System | Venous / peripheral vascular | Device / Robotics | First-in-human | Paraguay | 2025 | FIH completed | |
| FastWave Medical | Artero peripheral IVL system | Peripheral vascular (PAD) | Device / Robotics | First-in-human | Mexico | 2025 | FIH completed | NCT07209085 |
| Akura Medical | Katana Thrombectomy System | Pulmonary embolism / venous | Device / Robotics | First-in-human | Brazil, Dominican Republic | 2025 | Feasibility completed | EVToday |
| Horizon Surgical Systems | Polaris robotic cataract system | Ophthalmology / robotics | Device / Robotics | First-in-human | El Salvador | 2025 | FIH completed | Ophthalmology 360 |
| Ocumetics Technology | Bioelectronic accommodating lens | Ophthalmology | Device / Robotics | First-in-human | Mexico | 2025 | Enrolling (Group 2) | bioaccess blog |
How to read the Source column: Source labels that read “NCT…” link to a ClinicalTrials.gov registry record (company = sponsor of record; status as of July 2026). All other source labels link to the company’s own public announcement or an industry/trade article — device early-feasibility / first-in-human programs are often not registered on ClinicalTrials.gov. bioaccess® was not involved in the conduct of any study listed on this page.
Device and robotics pioneers are also choosing Latin America for first-in-human work. Recent examples include XCath (telerobotic stroke thrombectomy, Panama), SonoVascular (SonoThrombectomy, Chile), Nyra Medical (CARLEN mitral system, Brazil), Supira Medical (percutaneous VAD, Paraguay), ReValve Solutions (mitral replacement, Brazil), Nervonik (neuromodulation, Panama), Capstan Medical (robotic mitral valve replacement, Chile), Protaryx Medical (transseptal puncture, Paraguay), FastWave Medical (peripheral IVL, Mexico), Akura Medical (pulmonary-embolism thrombectomy, Brazil & Dominican Republic), Horizon Surgical (robotic cataract, El Salvador), and Ocumetics Technology (accommodating lens, Mexico). See our first-in-human clinical trials and LATAM FIH benchmarks for context on why device programs pick these markets.
Data compiled from ClinicalTrials.gov (industry lead-sponsor, interventional, Phase 1 / Early Phase 1, study start on or after 2023-01-01, with at least one registered site in a Latin American country) and public company announcements; retrieved July 2026. Information is believed accurate as of the retrieval date but is not independently verified beyond the cited public sources; registry data and study statuses change over time. Company, product, and trial names are trademarks or property of their respective owners and are used solely to identify publicly reported clinical-trial activity (nominative use). These organizations are independent third parties; their inclusion does not imply any affiliation with, sponsorship of, or endorsement by or of bioaccess®. bioaccess® was not involved in the conduct of the studies listed unless expressly stated. Counts reflect trials with a registered site in the country and may include multinational studies with sites elsewhere; the counts are ClinicalTrials.gov registry data only and do not include the press-release-sourced device rows. This list is a curated sample, not the full set, and inclusion or exclusion is not a statement about any company’s pipeline. The products referenced are investigational; nothing on this page is a statement about the safety or efficacy of any product, nor medical advice. This page is reviewed periodically (target: quarterly). To report an error or request a correction or removal, contact info@bioaccessla.com; we aim to respond within 10 business days. Last updated: July 2026.
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