Smarter decisions. Regulatory clarity. One platform.
5010 AI combines 25 years of FDA and EMA oncology data, live trial registries, guidance literature, and real-time news — with purpose-built AI analysis that helps drug development teams move faster, with confidence.
The intelligence layer for
oncology drug development.
From regulatory precedent to pipeline white space — Nexus puts 25 years of FDA and EMA oncology data, live trial registries, guidance literature, and real-time news into one platform, with AI analysis built in.
Approval Analytics
Self-guided dashboards across 800+ FDA approvals — filter by indication, pathway, sponsor, endpoint and year.
Regulatory Signal
Read, search and summarise FDA, EMA & ICH guidance documents with expert AI analysis and instant Q&A.
Oncology Pulse
Real-time FDA, EMA & global oncology approvals, guidance updates and regulatory news — curated daily.
Landscape Intelligence
Deep-dive reports across FDA & EMA approvals, live trials and literature — white space, pipeline and strategy.
Label Intelligence
Ask anything about an FDA-approved oncology drug — Nexus identifies it, pulls the live USPI, and answers instantly.
The regulatory record,
made navigable.
Twenty-five years of FDA oncology approvals and over 700 EMA indications — structured, searchable, and enriched with pathways, endpoints, benefit-risk summaries, and approval timelines. No more hunting through PDFs.
- 800+ FDA approvals with full regulatory metadata
- EMA CHMP opinions, conditional MAs and PRIME designations
- Filter by indication, sponsor, pathway, endpoint, year
Strategic intelligence,
not just data.
Nexus doesn't surface tables — it generates landscape briefings that reason across sources. White space mapped against what's approved and what's in trial. Pipeline gaps assessed with confidence scores and pathway recommendations.
- AI-generated landscape reports with heatmaps and opportunity cards
- US/EU regulatory comparison and benefit-risk divergence analysis
- Go Deeper on any section with Opus-powered drill-down
Always current,
always cited.
Live clinical trial data from ClinicalTrials.gov, real-time approval news, and peer-reviewed literature — all synthesised at the moment you ask. Every claim is source-attributed, so your team can verify before they act.
- Live ClinicalTrials.gov integration — active, recruiting and upcoming
- PubMed literature retrieval with PMID-level citations
- Oncology Pulse: daily-curated approvals, guidance and news
The right intelligence,
for every role.
Nexus isn't a single tool — it's an intelligence layer built around the distinct questions that regulatory, clinical, and market access teams face. Each role gets purpose-built reports grounded in the data that matters to their decisions.
Every precedent you need.
None of the PDF hunting.
Regulatory strategy depends on knowing what's been approved, on what basis, and by which pathway. Nexus gives you 25 years of structured FDA and EMA oncology approval data — searchable by indication, pathway, endpoint, sponsor, and benefit-risk profile — with AI that synthesises precedent into a strategic briefing on demand.
From white space to
trial-ready strategy.
Before a program enters the clinic, you need to know the competitive landscape, regulatory precedent, and where the genuine opportunity sits. Nexus generates deep-dive landscape reports in minutes — synthesising FDA and EMA approvals, live trials from ClinicalTrials.gov, and PubMed literature into a cited, structured briefing with confidence scores and pathway recommendations.
Payer intelligence,
grounded in evidence.
Market access decisions depend on understanding the full evidence landscape — not just what's approved, but how regulators and HTA bodies have assessed clinical benefit, comparators, and unmet need. Nexus generates market access reports synthesising regulatory precedent alongside HTA assessments from NICE, G-BA, HAS and others.
Three steps to
actionable intelligence.
Built for oncology. Ready for wherever the science leads.
No setup, no data uploads, no waiting. Ask a question in plain language — Nexus pulls from every relevant source in real time and returns a structured, cited briefing. From first query to deep-dive report in minutes.
Describe your question
in plain language.
Type any indication, mechanism, strategic question, or competitive scenario. No special syntax, no filters to configure. Nexus understands the domain context — whether you're asking about a tumour type, a biological pathway, a specific drug, or a cross-regional regulatory question.
Example queries:
Nexus pulls from every
relevant source.
In real time, Nexus queries its curated oncology dataset alongside live external APIs. Every source is weighted, cross-referenced, and synthesised by Claude Opus — not just retrieved and listed. Regulatory precedent, trial data, literature, and HTA assessments are reasoned across together.
A cited briefing, ready
to act on.
Nexus returns a structured, source-attributed report — not a wall of text. White space, pipeline gaps, regulatory divergence, and strategic implications are surfaced as discrete, verifiable findings. Every claim links to its source. Go Deeper on any section for Opus-powered drill-down at any moment.
Your therapeutic focus
shouldn't limit your intelligence.
Science doesn't stay in one lane. A CAR-T mechanism explored in lymphoma has implications for autoimmune disease. An IO checkpoint studied in NSCLC opens doors in dermatology. A market access strategy developed for oncology applies to rare disease. Nexus isn't locked to a single therapeutic area — it follows the mechanism, the pathway, and the evidence wherever it leads. Business development teams, clinical strategists, and pipeline architects can explore adjacencies across immunology, rare diseases, CNS, and beyond — all from the same platform, with the same depth of AI-powered synthesis.
Deep dive Landscape Reports
built for drug development teams
Describe any indication, mechanism, or strategic question. Nexus synthesises FDA and EMA precedents, live trial data, and literature into a structured briefing — in seconds.
Built for Drug Development Teams
What teams are saying
about Nexus.
Roles and company descriptions are real.
Early access programme, 2025.
Joining the early access programme — we're onboarding a limited number of pilot partners ahead of full launch. Feedback shapes the product directly.
Request access →Ready to see Nexus in action?
Request early access or book a guided walkthrough with the 5010 AI team. Now accepting a limited number of pilot partners.
Contact Us
Interested in our current products? Fill out some info and we will be in touch shortly. We can’t wait to hear from you!