Industry Trials starting in 2025

A review of industry-sponsored interventional studies, starting January 1, 2025, or later, reveals where development dollars are flowing and how the pipeline is evolving. The data highlights concentration in early development, persistent dominance of oncology, and an unmistakable surge in obesity and metabolic disease.

Trials by Phase

• Phase 1: 1,207 (26%)
• Phase 2: 853 (19%)
• Phase 3: 764 (17%)
• Phase 1–2: 415 (9%)
• Phase 4: 125 (3%)
• Early Phase 1: 58 (1%)
• Not Applicable (mostly devices/diagnostics): 1,095 (24%)

Most activity is clustered in early-stage trials, indicating a broad push to test new mechanisms with high attrition risk but long-term upside.

Top Conditions

Oncology leads but is no longer the only growth engine:

• Advanced Solid Tumors: 73
• Obesity: 66
• Breast Cancer: 44
• Ovarian Cancer: 36
• Atopic Dermatitis: 31
• Type 2 Diabetes: 28
• Heart Failure: 27

The data confirms oncology’s central role while showing significant investment in metabolic disease programs, driven by GLP-1 momentum and expanding into cardiometabolic indications.

Intervention Types

• Drugs: 62%
• Devices: 16%
• Biologicals: 10%
• Dietary Supplements: 4%
• Other categories: <5% combined

The pipeline remains overwhelmingly drug-dominated, with devices as a distant second. Biologics and advanced modalities remain relatively small in volume despite outsized attention in headlines.

Leading Sponsors

Top 10 companies by number of new trial starts in 2025+:

1. AstraZeneca – 93
2. Eli Lilly – 65
3. Merck – 64
4. Pfizer – 53
5. AbbVie – 53
6. Novartis – 50
7. Bristol-Myers Squibb – 43
8. Boehringer Ingelheim – 40
9. Qilu Pharma – 40
10. Sanofi – 39

The largest global pharma companies continue to drive the majority of new starts, reinforcing their control over high-value therapeutic areas.

Trendline

Trial initiations rise steadily month by month in 2025, indicating a rebound in sponsor confidence and sustained investment into 2026–27.

Outlook

• The front-loaded pipeline suggests significant volatility as early trials progress, with high failure rates but opportunities for step-change advances.
• Oncology remains the anchor, though obesity and cardiometabolic disease now rival it as growth engines.
• Devices and biologics contribute a meaningful but secondary share, unlikely to surpass drug trials in the near term.
• The largest multinational sponsors continue to dominate trial starts, consolidating influence over the development landscape.

Summary

Industry Trials starting 2025 onward

• 4,600+ new industry-sponsored interventional trials start from 2025 onward
• Phases: 26% Phase 1, 19% Phase 2, 17% Phase 3, 24% Not Applicable (devices/diagnostics)
• Top conditions: Advanced solid tumors (73), obesity (66), breast & ovarian cancer (80 combined), atopic dermatitis (31), type 2 diabetes (28), heart failure (27)
• Interventions: 62% drugs, 16% devices, 10% biologics
• Leading sponsors: AstraZeneca (93), Eli Lilly (65), Merck (64), Pfizer (53), AbbVie (53), Novartis (50)

Source: clinicaltrials.gov

Clinical Trial News 18-Sep-2025

Here’s the latest roundup of news, trends, deals, updates, breakthroughs, and projections in clinical trials and biotechnology:

Breaking News

The FDA has published 89 complete response letters (CRLs) for the first time, signaling a new era of transparency (FDA press release). The agency will now release CRLs in real time.

In parallel, the FDA unveiled the Rare Disease Evidence Principles, a framework that encourages the use of flexible endpoints, external controls, and adaptive designs in small or heterogeneous populations.

On the approvals front, Wayrilz (rilzabrutinib) gained clearance for adults with chronic or persistent immune thrombocytopenia (FDA approval). Vonvendi (recombinant von Willebrand Factor) secured expanded use to include peri-operative and on-demand treatment in children, as well as prophylaxis in adults (FDA announcement).

Across the Atlantic, the EMA’s PRAC opened a safety review of levamisole, underscoring Europe’s vigilance on older generics (EMA release).

Industry Trends

The ClinicalTrials.gov Protocol Registration System (PRS) is undergoing a modernization overhaul with cleaner workflows and enhanced results editing tools (PRS Tech Bulletin; Release Notes). The goal is to achieve better compliance and reduce friction for sponsors.

The NIH has extended flexibility for prospective basic experimental studies with humans (BESH), providing academic researchers with additional time for registration and results reporting (NIH announcement).

Meanwhile, universities are tightening their own disclosure rules. The University of Rochester rolled out a revised public posting policy, ensuring faster updates for secondary outcomes.

Regulatory Updates

Beyond CRL transparency, the FDA launched a “Green List” to block imports of illegal GLP-1 ingredients (FDA press). On the European side, the review of levamisole serves as a reminder of the continent’s proactive pharmacovigilance.

The agency’s “What’s New” page features new drug snapshots and label updates, which are posted weekly.

M&A and Licensing

The season’s biggest deal: Novartis signed an up-to-$5.2 billion licensing pact with Argo Biopharma, covering siRNA cardiometabolic assets outside China (Reuters, FT).

Meanwhile, Sanofi’s $470 million acquisition of Vigil Neuroscience is moving toward close this quarter (Reuters).

With pharma/biotech M&A already topping $100 billion YTD, analysts expect the momentum to hold through year’s end (Reuters overview).

R&D News

Chinese biotech Akeso has reported a promising survival benefit in its lung cancer trial, positioning its PD-1/VEGF bispecific as a potential challenger to Keytruda (STAT). This development is one to watch, as it has the potential to reshape the landscape of lung cancer treatment.

Summit’s ivonescimab remains a candidate to watch as Western readouts approach (STAT preview).

Not all news was positive: Zymeworks' decision to terminate its T-cell engager program after a benefit-risk reassessment has added to the industry's growing concerns around TCEs (FierceBiotech).

Tech Breakthroughs

AI continues to infiltrate drug development. Industry surveys indicate that capabilities are ready, but adoption lags by years (Applied Clinical Trials; AI & RWE protocols).

The most ambitious move: Oxford’s Vaccine Group won £118 million in funding from the Ellison Institute to launch AI-powered human challenge trials for antimicrobial-resistant pathogens (FT).

Future Projections

Expect more China-origin licensing deals in RNA and cardiometabolic disease, modeled on the Novartis–Argo playbook. The FDA’s Rare Disease Evidence Principles are likely to accelerate filings from smaller sponsors (FDA guidance).

With PRS modernization and the FDA’s new disclosure stance, sponsors should prepare for closer scrutiny of protocol amendments, endpoints, and outliers (PRS bulletin).

Summary Table

Category	Key Highlights	Links
Breaking News	FDA CRLs, Rare Disease Principles, Wayrilz, Vonvendi, EMA levamisole review	FDA press · Rare Disease · Wayrilz · Vonvendi · EMA review
Industry Trends	PRS modernization, NIH flexibilities, URMC policy	PRS Hub · PRS Bulletin · NIH Flexibility · URMC Policy
Approvals	Wayrilz (ITP), Vonvendi expanded use	Wayrilz · Vonvendi
Regulatory Updates	FDA “What’s New,” Green List, EMA safety review	FDA What's New · Green List · EMA review
M&A / Licensing	Novartis–Argo $5.2B, Sanofi–Vigil $470M, $100B+ YTD deals	Novartis–Argo · FT Coverage · Sanofi–Vigil · Deal Trends
R&D News	Akeso lung cancer, ivonescimab, Zymeworks exit	Akeso · Ivonescimab · Zymeworks
Tech Breakthroughs	AI adoption, Oxford Vaccine AI trial	AI Adoption · AI & RWE · Oxford Vaccine
Future Outlook	China licensing, rare-disease filings, PRS scrutiny	China Licensing · Rare Disease · PRS Bulletin

Sources: FDA, EMA, Reuters, Financial Times, STAT, FierceBiotech, Applied Clinical Trials.

Clinical Trial News 06-Sep-2025

Breaking News

• The FDA has published 89 complete response letters (CRLs) in real time for the first time, marking a new era of transparency: https://www.fda.gov/news-events/fda-newsroom/press-announcements
• The agency also issued new Rare Disease Evidence Principles: https://www.fda.gov/news-events/press-announcements/fda-advances-rare-disease-drug-development-new-evidence-principles
• Approvals landed in hematology: Wayrilz (rilzabrutinib) for chronic/persistent immune thrombocytopenia: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-adults-persistent-or-chronic-immune-thrombocytopenia
• Vonvendi (recombinant VWF) expanded to children and adult prophylaxis: https://www.fda.gov/news-events/press-announcements/fda-approves-expanded-use-vonvendi-von-willebrand-disease-including-certain-uses-children
• In Europe, the EMA’s PRAC launched a safety review of levamisole: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-1-4-september-2025

Industry Trends

• ClinicalTrials.gov’s PRS system is undergoing modernization: https://www.nlm.nih.gov/pubs/techbull/so25/so25_ct_prs.html
  
• Release notes: https://clinicaltrials.gov/about-site/release-notes
  
• Modernization hub: https://clinicaltrials.gov/about-site/modernization
• NIH announced flexibilities for BESH registration/results reporting: https://grants.nih.gov/news-events/nih-extramural-nexus-news/2025/07/flexibilities-for-registration-and-results-reporting-of-prospective-basic-experimental-studies-with-human-participants
  
• NIH Weekly Index: https://grants.nih.gov/grants/guide/weeklyindex.cfm
• University of Rochester posted a new policy (Sept 2025): https://www.urmc.rochester.edu/MediaLibraries/URMCMedia/Policy-Public-Disclosure-Clinical-Trials-Sept-25-2025.pdf

Approvals

• Wayrilz approval: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-adults-persistent-or-chronic-immune-thrombocytopenia
• Vonvendi expanded approval: https://www.fda.gov/news-events/press-announcements/fda-approves-expanded-use-vonvendi-von-willebrand-disease-including-certain-uses-children

Regulatory Updates

• FDA’s “What’s New” in Drugs page: https://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs
• FDA “Green List” initiative for illegal GLP-1 ingredients: https://www.fda.gov/news-events/fda-newsroom/press-announcements
• EMA levamisole review: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-1-4-september-2025

M&A and Licensing

• Novartis signed an up-to-$5.2B deal with Argo Biopharma: https://www.reuters.com/business/healthcare-pharmaceuticals/novartis-signs-up-52-billion-licensing-deal-with-argo-biopharmaceutical-heart-2025-09-03/
• Financial Times coverage: https://www.ft.com/content/d57325e4-5bc1-447c-a981-80820e17628a
• Sanofi’s $470M acquisition of Vigil Neuroscience: https://www.reuters.com/markets/deals/sanofi-acquire-vigil-neuroscience-470-million-deal-2025-05-21/
• Deal flow context ($100B+ in 2025): https://www.reuters.com/business/healthcare-pharmaceuticals/major-deals-involving-us-drugmakers-biotechs-over-past-decade-2025-07-09/

Other R&D News

• Akeso reported survival benefit in lung cancer trial: https://www.statnews.com/2025/08/26/akeso-says-its-closely-watched-drug-improved-patient-survival-in-a-lung-cancer-trial/
• Summit Therapeutics’ ivonescimab preview: https://www.statnews.com/2025/05/15/summit-therapeutics-ivonescimab-lung-cancer-preview/
• Zymeworks dropped a T-cell engager program: https://www.fiercebiotech.com/biotech/zymeworks-drops-clinical-stage-t-cell-engager-after-assessing-benefit-risk-profile

Tech Breakthroughs

• AI adoption in clinical trial operations/design: https://www.appliedclinicaltrialsonline.com/view/clinical-trial-innovations-gain-adoption
• AI & RWE master protocols: https://www.appliedclinicaltrialsonline.com/view/ai-ml-real-world-evidence-master-protocols-trial-success
• Oxford Vaccine Group awarded £118M for AI-powered human challenge trials: https://www.ft.com/content/e21af386-2171-4d2d-a4a6-9d52761261ff

Future Projections

• China-origin licensing deals expected to accelerate (Novartis–Argo as template): https://www.reuters.com/business/healthcare-pharmaceuticals/novartis-signs-up-52-billion-licensing-deal-with-argo-biopharmaceutical-heart-2025-09-03/
• Rare Disease Evidence Principles to shape new filings: https://www.fda.gov/news-events/press-announcements/fda-advances-rare-disease-drug-development-new-evidence-principles
• ClinicalTrials.gov PRS enhancements increasing scrutiny: https://www.nlm.nih.gov/pubs/techbull/so25/so25_ct_prs.html

Category	Key Highlights	Links
Breaking News	FDA CRLs, Rare Disease Principles, Wayrilz, Vonvendi, EMA levamisole review	FDA press | Rare Disease Principles | Wayrilz | Vonvendi | EMA review
Industry Trends	PRS modernization, NIH flexibilities, URMC policy	PRS Hub | PRS Bulletin | NIH Flexibility | URMC Policy
Approvals	Wayrilz (ITP), Vonvendi expanded use	Wayrilz | Vonvendi
Regulatory Updates	FDA “What’s New,” Green List, EMA safety review	FDA What's New | Green List | EMA review
M&A / Licensing	Novartis–Argo $5.2B, Sanofi–Vigil $470M, $100B+ YTD deals	Novartis–Argo | FT Coverage | Sanofi–Vigil | Deal Trends
R&D News	Akeso lung cancer, ivonescimab, Zymeworks exit	Akeso | Ivonescimab | Zymeworks
Tech Breakthrus	AI adoption, Oxford Vaccine AI trial	AI Adoption | AI & RWE | Oxford Vaccine
Future Outlook	China licensing, rare-disease filings, PRS scrutiny	China Licensing | Rare Disease | PRS Bulletin