Clinical Trials
2911
550 active
Approvals
105
Total approvals
Agencies
4
Regulatory bodies
Founded
N/A
Not yet recruiting
19
0.7%
No Longer Available
3
0.1%
Terminated
279
9.6%
Recruiting
386
13.3%
Suspended
1
0.0%
Approved For Marketing
2
0.1%
Withdrawn
50
1.7%
Active, not recruiting
531
18.2%
Unknown
3
0.1%
Completed
1637
56.2%
- Par Health received final FDA approval and launched the first generic version of Merck's Janumet® XR (sitagliptin and metformin HCl extended-release) tablets in the U.S. - Janumet® XR had estimated annual U.S. sales of approximately $269.9 million for the 12 months ended May 2026, according to IQVIA data. - The first-to-market generic entry aims to expand patient access to more affordable treatment options for type 2 diabetes. - The launch strengthens Par Health's generics portfolio and underscores the company's commitment to delivering quality, low-cost essential medicines.
- Long-term follow-up of KEYNOTE-966 shows the addition of pembrolizumab to gemcitabine and cisplatin maintained a clinically meaningful overall survival benefit with no new safety signals. - Overall grade 3 or 4 adverse event rates were comparable between treatment arms, with cytopenias as the most common events attributable to the chemotherapy backbone. - Immune-mediated adverse events and infusion reactions occurred more often with pembrolizumab, most commonly hypothyroidism and pneumonitis. - The data align with TOPAZ-1 findings, where grade 3 or 4 adverse events were similar between arms and immune-mediated events were generally manageable.
- Liquidia Corporation achieved preliminary full-year 2025 net sales of $148.3 million for YUTREPIA, its inhaled treprostinil therapy for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. - The company treated over 2,200 patients and received more than 2,800 unique prescriptions since YUTREPIA's regulatory approval in May 2025, demonstrating strong market adoption. - Liquidia plans to initiate multiple clinical studies in 2026 to expand YUTREPIA's applications, including trials in idiopathic pulmonary fibrosis and systemic sclerosis-associated Raynaud's phenomenon. - The company generated over $30 million in positive cash flow during Q4 2025 and maintained approximately $190.7 million in cash reserves as of December 31, 2025.
- DelveInsight's latest pipeline report reveals over 70 companies are actively developing more than 75 therapeutic candidates for HER2-negative breast cancer treatment. - Recent clinical trials include Washington University's Phase II study of PD 0332991 combined with anastrozole for early-stage ER+ breast cancer and MedSIR's Phase II trial investigating improved tolerance of sacituzumab govitecan. - Leading pipeline candidates include Genentech's Giredestrant (Phase III SERD), Inavolisib (Phase III PI3Kα inhibitor), and CytomX's conditionally activated antibody-drug conjugate CX-2009. - Merck Sharp & Dohme initiated a Phase III study evaluating Sac-TMT followed by carboplatin/paclitaxel versus chemotherapy in combination with pembrolizumab for high-risk triple-negative breast cancer.
- CytomX Therapeutics announced initial Phase 1 biomarker data for CX-801, a masked interferon alpha-2b PROBODY cytokine, demonstrating tumor-selective interferon signaling activation in advanced melanoma patients. - The data show CX-801 induces tumor-localized activation of immune cell populations and interferon-stimulated genes including PD-1 and PD-L1 in paired tumor biopsies. - CX-801 appears generally well tolerated and can modulate the immune tumor microenvironment in metastatic melanoma patients refractory to prior immune checkpoint inhibitor therapy. - The findings support the ongoing Phase 1 combination study of CX-801 with KEYTRUDA in melanoma, with clinical data expected in 2026.
- The Patent Trial and Appeals Board issued final written decisions on September 18-19, 2025, finding all claims in four Johns Hopkins pembrolizumab patents unpatentable in challenges brought by Merck. - The disputed patents cover the use of pembrolizumab (KEYTRUDA) for treating colorectal cancer and solid tumors in patients with microsatellite instability-high or mismatch repair deficiency. - The decisions are part of a broader intellectual property dispute involving nine inter partes reviews filed by Merck against Johns Hopkins patents related to their research collaboration on pembrolizumab effectiveness. - Four additional IPR cases remain pending with extended deadlines through November 2025, while Merck reported $29.5 billion in worldwide KEYTRUDA sales in 2024.
- Formycon AG successfully completed patient enrollment for its Dahlia pharmacokinetic study with 96 participants, comparing biosimilar candidate FYB206 to Keytruda in melanoma patients. - The FDA approved a streamlined clinical development program allowing Formycon to skip the Phase III trial, accelerating development and reducing costs significantly. - Results from the primary endpoint are expected in Q1 2026, with potential market entry after Keytruda's exclusivity expires in 2029 for the US and 2030 for the EU. - The development targets the world's best-selling drug with $29.5 billion in 2024 sales, potentially reaching over $50 billion by 2032.
- BioInvent successfully developed a population model to characterize BI-1910 pharmacokinetics and pharmacodynamics across a broad dose range, supporting optimal dose selection for upcoming Phase 2a studies. - The anti-TNFR2 agonist antibody demonstrated stable disease in six out of 12 evaluable patients during Phase 1 dose escalation, with favorable pharmacokinetics and robust target engagement inducing T cell proliferation. - Phase 2a studies of BI-1910 as both single agent and in combination with pembrolizumab are planned to initiate in the second half of 2025, targeting hepatocellular cancer and other solid tumors.
- DelveInsight's 2025 report reveals over 80 companies are actively developing more than 80 pipeline therapies for pancreatic ductal adenocarcinoma treatment. - Key pharmaceutical companies including Genentech, Revolution Medicines, and Merck Sharp & Dohme are conducting Phase 3 trials with promising novel therapeutic approaches. - Emerging therapies such as Onvansertib, Nadunolimab, and Zimberelimab represent diverse mechanisms of action targeting treatment resistance and immune suppression in pancreatic cancer. - Recent regulatory approvals include Anocca's VIDAR-1 Phase I/II trial targeting KRAS-positive advanced pancreatic cancer, demonstrating growing focus on precision medicine approaches.
• DelveInsight's latest report reveals a robust pipeline with 110+ companies developing 120+ therapies for acute myeloid leukemia (AML), showing significant investment in this aggressive blood cancer. • Several promising candidates are advancing through clinical trials, including GlycoMimetics' uproleselan in Phase III, BioSight's aspacytarabine (BST-236) in Phase II, and novel approaches like Senti Biosciences' logic-gated CAR-NK cell therapy. • Recent developments include Moleculin Biotech's Phase III MIRACLE trial for annamycin, Qurient's adrixetinib IND approval, and Rigel Pharmaceuticals' trial of REZLIDHIA in combination therapy for IDH1-mutated AML.
