Clinical Trials
219
65 active
Approvals
179
Total approvals
Agencies
6
Regulatory bodies
Founded
N/A
Active, not recruiting
36
16.4%
Completed
86
39.3%
Not yet recruiting
29
13.2%
Recruiting
52
23.7%
Terminated
5
2.3%
Unknown
4
1.8%
Withdrawn
6
2.7%
- Sun Pharma will present updated long-term follow-up data for UNLOXCYT (cosibelimab-ipdl) in locally advanced cutaneous squamous cell carcinoma at ASCO 2026, representing the second largest prospective study of its kind. - The study demonstrated a 50% objective response rate with 27% complete responses in 64 patients, with median duration of response not yet reached after over 31 months of follow-up. - The treatment showed a manageable safety profile with only one patient experiencing Grade ≥3 immune-related adverse events, supporting its use in elderly patients with multiple comorbidities. - UNLOXCYT is indicated for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.
- Sun Pharmaceutical Industries Limited announced a definitive agreement to acquire Organon & Co. for $14.00 per share in an all-cash transaction valued at $11.75 billion. - The acquisition will position Sun Pharma among the top 25 global pharmaceutical companies with combined revenues of $12.4 billion and establish it as the 7th largest global biosimilar player. - The deal creates a top 3 global women's health company and enables Sun Pharma's entry into biosimilars while expanding its presence to 150 countries across 18 major markets. - The transaction is expected to close in early 2027, subject to regulatory approvals and Organon stockholder approval, with financing through cash resources and committed bank funding.
- Novartis AG has executed a definitive agreement to sell its entire 70.68% controlling stake in Novartis India Limited to a consortium of three investment firms for approximately $345 million. - The transaction automatically triggers a mandatory open offer under SEBI regulations, requiring the acquiring consortium to offer purchase opportunities to all remaining public shareholders. - Novartis India's recent financial performance shows declining trends with Q3 revenue falling 8% year-over-year to ₹859 million and net profit dropping 37% to ₹161 million. - The strategic divestment allows Novartis AG to retain its R&D operations through Novartis Healthcare Private Limited while exiting commercial operations in India's competitive pharmaceutical market.
- OneSource Specialty Pharma reported a 26% year-over-year revenue decline to ₹2,903 million in Q3FY26, primarily due to delayed customer approvals for semaglutide in Canada. - The company's EBITDA plummeted 88% to ₹173 million with margins collapsing from 36% to 6%, while net profit swung to a significant loss of ₹887 million. - Despite quarterly setbacks, OneSource reaffirmed its FY28 guidance targeting $400 million in organic revenue and highlighted the growing GLP-1 market opportunity projected to reach $170 billion by 2033. - The regulatory delay affects OneSource's manufacturing partnership with Dr. Reddy's Laboratories for semaglutide, as Health Canada issued a Notice of Non-Compliance impacting market entry timelines.
- Adimab announced 11 new partner programs entered clinical trials in 2025, bringing the total number of clinical programs to 89 since 2009. - Six therapeutic products containing Adimab-discovered or optimized molecules have received commercial approval, including GSK's Exdensur for severe asthma. - The company's antibody discovery platform has generated over 650 therapeutic programs across partnerships with more than 140 pharmaceutical and biotechnology companies. - Adimab Royalty Company structure, established in 2024, is now generating revenue from the first wave of approved products containing the company's molecules.
- Danish pharmaceutical giant Novo Nordisk is set to launch its blockbuster diabetes drug Ozempic in India within the next three to four weeks this December. - India represents a critical market opportunity with the second-highest number of type 2 diabetes patients globally after China and rising obesity rates. - The launch comes as Novo faces stiff competition from Eli Lilly's Mounjaro, which sold 262,000 doses in October compared to Wegovy's 26,000 doses. - Analysts predict the global weight-loss treatment market could reach $150 billion annually by the end of this decade.
- The FDA approved an updated label for UNLOXCYT (cosibelimab-ipdl) incorporating long-term follow-up data from the pivotal CK-301-101 trial showing improved objective response rates in advanced cutaneous squamous cell carcinoma. - At least 50% of patients achieved objective response in the 109-patient study, with median duration of response not reached in either metastatic or locally advanced cohorts at time of analysis. - UNLOXCYT represents the first and only PD-L1 immune checkpoint inhibitor approved for advanced CSCC, offering a unique mechanism that spares PD-L2 and engages both adaptive and innate immune systems. - Sun Pharma plans to commercially launch UNLOXCYT in early 2026, addressing significant unmet needs for the approximately 40,000 advanced CSCC cases annually in the United States.
- President Trump announced 100% tariffs on all imported branded and patent-protected medicines to the US starting October 1, 2025, unless companies are actively building manufacturing plants in America. - Indian pharmaceutical stocks plummeted up to 5% following the announcement, with Sun Pharma hitting its yearly low and the Nifty Pharma Index declining 2.54%. - The policy could significantly impact Indian pharma companies that generate substantial revenue from US exports, potentially affecting over $233 billion of US pharma imports while exempting generic drug exporters. - Companies may face reduced profits or be forced to invest in expensive US manufacturing facilities to avoid the tariffs and maintain market access.
- Sun Pharma is preparing to launch Unloxcyt (cosibelimab) for advanced cutaneous squamous cell carcinoma in the second half of FY26, pending U.S. FDA approval. - The company's global specialty business grew 16% year-on-year to $333 million, driven by flagship products including Ilumya, Cequa, Winlevi, and Odomzo. - Sun Pharma invested ₹782.7 crore in R&D during Q3, representing 5.4% of revenue, with six novel entities currently in clinical stage development. - Analysts maintain 'BUY' ratings with target prices ranging from ₹1,875 to ₹2,000, citing strong specialty pipeline visibility and sustained growth momentum.
- Sun Pharma received CDSCO panel approval to conduct a Phase IV clinical trial for Esomeprazole Dual Release gastro-resistant tablets 80 mg following detailed committee deliberation. - The dual release formulation is designed to provide prolonged acid suppression for improved therapeutic outcomes in acid-related gastrointestinal disorders including GERD and peptic ulcer disease. - This post-marketing clinical investigation will generate additional safety and efficacy data under routine clinical use conditions for the higher-dose specialized formulation. - The approval follows regulatory requirements for monitoring real-world performance of specialized PPI formulations in clinical practice.
