Radiopharmaceutical Clinical Trials — U.S. & Latin America: Lu-177, Ac-225, and Ga-68 Strategies

How Latin America's nuclear medicine infrastructure, regulatory frameworks, and cost advantages are making it the new frontier for radioligand therapy and theranostic clinical trials.

March 25, 2026

20

min read

By

Julio G. Martinez-Clark, CEO, bioaccess®

Radiopharmaceuticals

Lu-177

Ac-225

Ga-68

Latin America

Theranostics

Nuclear Medicine

Clinical Trials

The Radiopharmaceutical Revolution — and Why Latin America Is Positioned to Lead

The global radiopharmaceutical market is undergoing a transformation unprecedented in the history of nuclear medicine. Novartis's Pluvicto® (Lu-177 PSMA-617), approved by the FDA in March 2022 for metastatic castration-resistant prostate cancer, generated over $1 billion in sales within its first full year — demonstrating that radioligand therapy (RLT) has crossed the threshold from academic curiosity to commercial blockbuster. The pipeline behind it is massive: over 300 radiopharmaceutical clinical trials are active globally, with companies like RayzeBio (acquired by Bristol-Myers Squibb for $4.1 billion), Fusion Pharmaceuticals (acquired by AstraZeneca for $2.4 billion), and Point Biopharma (acquired by Eli Lilly for $1.4 billion) commanding extraordinary acquisition premiums.

Yet the clinical trial infrastructure required for radiopharmaceutical development — cyclotrons, hotlabs, radiopharmacy compounding, PET/CT and SPECT/CT imaging, nuclear waste management, and radiation safety protocols — remains concentrated in a handful of US and European academic medical centers. The result: intense competition for trial slots, spiraling per-patient costs ($60K–$120K in the US), and enrollment timelines that can stretch beyond 24 months.

Latin America offers a compelling alternative. Brazil operates South America's most extensive cyclotron network through IPEN (Instituto de Pesquisas Energéticas e Nucleares). Argentina's CNEA (Comisión Nacional de Energía Atómica) has been producing medical isotopes for decades and is investing in Ac-225 production. Mexico's ININ (Instituto Nacional de Investigaciones Nucleares) provides regional isotope supply. Colombia's nuclear medicine departments — particularly at Fundación Santa Fe de Bogotá, Hospital San José, and CIRA Health — have the imaging infrastructure and trained nuclear medicine physicians to execute sophisticated theranostic protocols.

bioaccess® operates the most experienced radiopharmaceutical clinical trial program with U.S. regulatory anchoring and Latin American execution — from isotope sourcing and decay-window logistics to patient dosimetry and FDA-submissible data packages.

The Big Three Radiopharmaceuticals: Lu-177, Ac-225, and Ga-68

Three isotopes dominate the current radiopharmaceutical clinical landscape, each with distinct clinical applications, half-life constraints, and supply chain considerations that directly impact trial design and site selection.

Lutetium-177 (Lu-177): The Beta-Emitting Workhorse

Lu-177 is a beta-emitting radionuclide with a 6.647-day half-life that has become the backbone of radioligand therapy. Its medium-energy beta emissions (Eβmax = 498 keV) deliver cytotoxic radiation to tumor cells with a tissue penetration range of approximately 2 mm — sufficient to destroy targeted cancer cells while limiting damage to surrounding healthy tissue. The accompanying gamma emissions (208 keV, 11%) enable post-therapy SPECT/CT imaging for dosimetry verification.

The two primary Lu-177 radiopharmaceuticals in clinical development are Lu-177-DOTATATE (Lutathera®) for neuroendocrine tumors and Lu-177-PSMA-617 (Pluvicto®) for prostate cancer. Beyond these approved agents, dozens of novel Lu-177 conjugates targeting different tumor antigens are in Phase I and Phase II trials globally.

**Lu-177 Supply in Latin America**

Brazil's IPEN cyclotron in São Paulo produces Lu-177 domestically, eliminating international shipping delays. Argentina's CNEA reactors at the Ezeiza Atomic Centre also produce Lu-177 for regional distribution. For LATAM trials, bioaccess® coordinates isotope procurement with a 48–72 hour delivery window from production to patient administration — well within the 6.7-day half-life decay window.

Actinium-225 (Ac-225): The Alpha Therapy Frontier

Ac-225 is an alpha-emitting radionuclide with a 10-day half-life that generates four alpha particles in its decay chain — delivering an extraordinarily high linear energy transfer (LET) of approximately 100 keV/μm to targeted cancer cells. This makes Ac-225-based targeted alpha therapy (TAT) potentially orders of magnitude more cytotoxic than beta-emitting RLT, with the ability to induce irreparable DNA double-strand breaks even in radioresistant tumors.

The clinical promise of Ac-225 is enormous: early clinical data from Ac-225-PSMA-617 studies have shown responses in patients who progressed on Lu-177-PSMA-617. However, Ac-225 supply remains the critical bottleneck. Global production capacity is estimated at less than 2 curies per year from all sources combined. Argentina's CNEA has invested in Ac-225 production research, and several international collaborations are working to scale production using linear accelerators and thorium-229 generators.

For sponsors developing Ac-225 radiopharmaceuticals, bioaccess® coordinates with international Ac-225 suppliers and manages the complex logistics of the 10-day half-life window, including customs clearance, radiation safety documentation, and temperature-controlled transport.

Gallium-68 (Ga-68): The Diagnostic Companion

Ga-68 is a positron-emitting radionuclide with a 68-minute half-life used exclusively for PET diagnostic imaging. Ga-68-DOTATATE (NETSPOT®) for neuroendocrine tumor imaging and Ga-68-PSMA-11 (Locametz®) for prostate cancer staging are both FDA-approved companion diagnostics that play a critical role in patient selection for Lu-177 therapeutic trials.

The theranostic paradigm — "see it, treat it" — requires Ga-68 PET imaging to identify patients with sufficient target expression before administering Lu-177 or Ac-225 therapy. This means any site conducting radioligand therapy trials must also have Ga-68 PET/CT imaging capability.

Ga-68 is produced from germanium-68/gallium-68 generators, which can be installed at any nuclear medicine department with a PET/CT scanner. bioaccess®'s pre-qualified nuclear medicine sites in Brazil, Colombia, Mexico, and Argentina all have Ga-68 PET/CT capability for theranostic clinical trials.

Why Latin America for Radiopharmaceutical Clinical Trials?

Latin America offers four structural advantages that make it an increasingly attractive destination for radiopharmaceutical clinical development:

• Nuclear medicine infrastructure: Brazil (IPEN cyclotron, CNEN regulatory framework), Argentina (CNEA isotope production, 30+ nuclear medicine centers), Mexico (ININ, major PET/CT networks), and Colombia (CIRA Health, Fundación Santa Fe) provide the specialized facilities required for radiopharma trials.
• Cost efficiency: Per-patient costs of $25K–$50K for radiopharmaceutical trials in LATAM, compared to $60K–$120K in the US — a 40–60% reduction that preserves runway for biotech companies with limited capital.
• Regulatory pathways: ANVISA, INVIMA, COFEPRIS, and ANMAT all have established frameworks for radiopharmaceutical clinical investigations, with ethics committee approvals in 4–8 weeks versus 6–12 months in the US.
• Patient access: Large oncology patient populations with high disease burden — particularly prostate cancer (Brazil has the 2nd highest incidence in the Americas) and neuroendocrine tumors — support rapid enrollment and strong retention.

Regulatory Framework for Radiopharmaceutical Trials in Latin America

Radiopharmaceutical clinical trials require dual regulatory oversight: authorization from the national health authority for the clinical investigation itself, and nuclear safety authorization from the national nuclear regulatory body for the handling, transport, and administration of radioactive materials.

🇧🇷

Brazil

Health Authority: ANVISA (RDC 837/2023)

Nuclear Regulator: CNEN (Comissão Nacional de Energia Nuclear)

IPEN produces Lu-177 domestically. CONEP waiver available for early feasibility. Law 14874 caps ethics review at 30 business days.

🇦🇷

Argentina

Health Authority: ANMAT

Nuclear Regulator: ARN (Autoridad Regulatoria Nuclear)

CNEA produces Lu-177 and is investing in Ac-225 R&D. 30+ nuclear medicine departments. Strong PET/CT network in Buenos Aires.

🇲🇽

Mexico

Health Authority: COFEPRIS

Nuclear Regulator: CNSNS (Comisión Nacional de Seguridad Nuclear)

ININ provides isotope production. COFEPRIS Reliance framework. 2.8-month median trial start-up — fastest in LATAM.

🇨🇴

Colombia

Health Authority: INVIMA

Nuclear Regulator: SGC / ANE regulatory oversight

CIRA Health and Fundación Santa Fe offer nuclear medicine capabilities. INVIMA ethics approval in 4–6 weeks. Level 4 regulatory authority.

**GMP for Radiopharmaceuticals**

Radiopharmaceutical GMP requirements differ from conventional drug GMP. The short half-lives of therapeutic isotopes (Lu-177: 6.7 days, Ac-225: 10 days, Ga-68: 68 minutes) mean that batch release testing must be adapted — sterility testing may not be complete before administration. ANVISA, ANMAT, and COFEPRIS recognize international radiopharmaceutical GMP standards (PIC/S Annex 3, EU GMP Annex 3) and accept sponsor-controlled radiopharmacy protocols for investigational agents.

Clinical Site Requirements for Radiopharmaceutical Trials

Radiopharmaceutical trials demand specialized infrastructure that goes far beyond what standard clinical trial sites provide. bioaccess®'s site qualification process for radiopharma studies evaluates:

• Hotlab facilities: Shielded radiopharmacy laboratories with laminar flow hoods, dose calibrators, and quality control equipment for radiopharmaceutical preparation and dispensing.
• Nuclear medicine department: PET/CT scanners (for Ga-68 diagnostic imaging), SPECT/CT cameras (for Lu-177 post-therapy dosimetry), and gamma probes for intraoperative use where applicable.
• Radiation safety infrastructure: Designated radioactive waste storage, personnel dosimetry programs, radiation monitoring equipment, and emergency decontamination protocols compliant with national nuclear regulatory requirements.
• Patient isolation capabilities: Depending on the therapeutic isotope and administered activity, patients may require post-treatment isolation in shielded rooms until radiation levels fall below discharge thresholds.
• Experienced nuclear medicine physicians: Board-certified nuclear medicine specialists with experience in radionuclide therapy, familiar with EANM/SNMMI dosimetry guidelines and adverse event management for RLT.
• Cold chain and logistics: Capability to receive, store, and administer radiopharmaceuticals within the decay-window constraints — particularly critical for Ga-68 (68-minute half-life) and Ac-225 (10-day half-life).

The bioaccess® Radiopharmaceutical Trial Process

bioaccess® has developed a specialized clinical operations workflow for radiopharmaceutical trials that addresses the unique challenges of isotope logistics, regulatory complexity, and site qualification:

01

Protocol Design & Isotope Strategy

FDA-oriented protocol design with isotope-specific considerations: dosimetry plan, treatment cycles, imaging schedule, and safety monitoring tailored to your radiopharmaceutical's half-life and emission profile.

02

Country & Site Selection

Match your isotope to the optimal country based on domestic production capability (Lu-177 from IPEN/CNEA), import logistics feasibility, nuclear medicine infrastructure, and regulatory timeline.

03

Isotope Sourcing & Supply Chain

Establish primary and backup isotope supply chains with decay-window logistics planning. Coordinate with IPEN, CNEA, ININ, or international suppliers for reliable delivery within half-life constraints.

04

Dual Regulatory Submission

Parallel submissions to health authority (ANVISA/INVIMA/COFEPRIS/ANMAT) and nuclear regulatory body (CNEN/ARN/CNSNS). Ethics committee review runs concurrently to compress total approval timeline to 6–10 weeks.

05

Site Activation & Training

Radiopharmacy protocol training, dosimetry calibration, radiation safety review, and mock treatment sessions to ensure site readiness before first patient enrollment.

06

Treatment & Monitoring

ACRP-certified CRAs manage enrollment, isotope delivery coordination, treatment administration oversight, post-therapy imaging, dosimetry data collection, and safety reporting with weekly sponsor dashboards.

07

Dosimetry Analysis & CSR

Quantitative dosimetry analysis, biostatistical reporting, clinical study report preparation, and safety narratives — all formatted for FDA submission requirements.

08

FDA Bridge Strategy

Pre-submission meeting preparation, IND application support, and regulatory strategy for transitioning LATAM radiopharma data to US pivotal trials under 21 CFR 312.120.

**Decay-Window Logistics: The Critical Differentiator**

The single most important operational challenge in radiopharmaceutical trials is managing the decay window — the time between isotope production and patient administration. For Lu-177 (6.7-day half-life), bioaccess® maintains a 48–72 hour maximum transit window including customs clearance with INVIMA, ANVISA, or COFEPRIS. For Ga-68 (68-minute half-life), on-site Ge-68/Ga-68 generators are mandatory. bioaccess® is the only LATAM CRO with dedicated radiopharma supply chain protocols that account for these constraints.

Frequently Asked Questions About Radiopharmaceutical Trials in Latin America

Ready to Launch Your Radiopharmaceutical Trial in Latin America?

bioaccess® operates the most experienced radiopharmaceutical clinical trial program with U.S. regulatory anchoring and Latin American execution with dedicated capabilities — from isotope sourcing and decay-window logistics to patient dosimetry and FDA-submissible data packages. Whether you're developing a Lu-177 RLT, an Ac-225 targeted alpha therapy, or need Ga-68 PET imaging for patient selection, our nuclear medicine site network and specialized operations team can accelerate your clinical program by 6–12 months versus US pathways.

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