Core Insights - The 2026 Drugs to Watch report by Clarivate identifies eleven therapies expected to significantly impact clinical practice and achieve strong commercial potential in the coming year [1][2][3] - The report emphasizes the importance of anticipating emerging drug trends and understanding market dynamics to navigate the complex pharmaceutical landscape [3] Metabolic Disease - Orforglipron and Retatrutide, both developed by Eli Lilly, are highlighted for managing obesity and type 2 diabetes mellitus (T2DM) with innovative delivery methods [4][5] - The report projects obesity drug sales to reach USD 150 billion by 2035, emphasizing the need for real-world effectiveness and differentiation in safety and clinical value [16] Rare Conditions - Development in rare diseases is expanding into neurological, psychiatric, and hematologic conditions, requiring targeted engagement and evidence-driven approaches [17] - Therapies like VOYXACT® for immunoglobulin A nephropathy and Relacorilant for ovarian cancer are noted for their potential in these areas [8][13] Oncology - The report features therapies such as Gedatolisib for breast cancer and Tolebrutinib for multiple sclerosis, showcasing advancements in precision oncology [10][9] - The increasing complexity of regulatory pathways in the U.S. and Europe is highlighted as a challenge for companies developing treatments for rare diseases [17] Delivery Innovations - The report underscores the growing importance of delivery innovations, including extended-release formulations and oral alternatives to injectable drugs, which can enhance patient adherence [18] - Mainland China is emerging as a significant market and source of innovation, influencing global strategies in oncology and metabolic disease [18] Methodology and Analysis - The report's findings are based on evaluations from over 160 analysts using integrated, AI-enhanced datasets covering the full R&D and commercialization lifecycle [20][21] - Therapies were selected based on their potential to achieve blockbuster status, defined as reaching USD 1 billion in annual sales within five years [20]

Core Insights - The FDA's CDER approved 44 new drugs by 2025, with over half being "first-in-class" drugs, indicating a shift from "incremental" to "disruptive" treatment paradigms in drug development [1][3][24] - The rise of small molecules continues, but their development is evolving from broad inhibition to precision modulation, enhancing efficacy while reducing side effects [6][7][9][10] First-in-Class Drugs - The approval of "first-in-class" drugs is driven by unmet clinical needs, particularly in rare and complex chronic diseases, where existing treatments are inadequate [3][4] - Brinsupri (brensocatib) is a notable example, targeting Dipeptidyl Peptidase 1 (DPP1) to address non-cystic fibrosis bronchiectasis, providing a new mechanism of action that significantly improves patient outcomes [3][20] - Eight drugs received breakthrough therapy designation, reflecting their innovative mechanisms and potential for substantial clinical improvement [5] Small Molecule Innovations - Small molecules accounted for 66% of new drug approvals, maintaining their central role in drug development while shifting towards precision approaches [6][10] - Aficamten (Myqorzo) exemplifies this trend as a selective allosteric modulator for obstructive hypertrophic cardiomyopathy, demonstrating improved safety and efficacy [7] - Covalent drugs, such as Zegfrovy (sunvozertinib), show promise in overcoming resistance issues by forming stable bonds with targets, enhancing therapeutic effectiveness [8] Peptide and Nucleic Acid Therapies - Peptide and nucleic acid therapies are emerging as significant players, with multiple innovative drugs approved in 2025, marking a shift towards RNA-targeted treatments [10][11] - Qfitlia (fitusiran) offers a revolutionary preventive solution for hemophilia by significantly reducing annual bleeding rates [10][12] - Dawnzera (donidalorsen) provides a long-acting preventive treatment for hereditary angioedema, demonstrating substantial reductions in attack frequency [11] Antibody-Drug Conjugates (ADCs) - ADCs are evolving beyond cancer treatment, with Datroway (datopotamab deruxtecan) showcasing innovative mechanisms and expanding indications [14][15] - Datroway's "bystander effect" allows it to target heterogeneous tumor populations effectively, improving treatment outcomes in breast cancer and non-small cell lung cancer [15][16] Future Directions - The landscape of drug development is shifting towards a broader understanding of drug value, emphasizing patient outcomes and treatment paradigms over traditional sales metrics [19][23] - The integration of advanced technologies like AI and gene editing into drug development processes is expected to yield therapies that fundamentally alter disease progression [24]

Core Viewpoint - GlaxoSmithKline (GSK) has received FDA approval for its new asthma treatment, Exdensur (depemokimab), which is expected to pave the way for the drug to become a blockbuster product [1] Group 1: Regulatory Approvals - Exdensur has been approved by the FDA as an additional maintenance therapy for patients aged 12 and older with severe asthma [1] - Earlier this month, the drug received marketing authorization from the European Medicines Agency, and the UK regulatory body has also given it the green light [1] - The drug's applications in China and Japan are currently under review [1] Group 2: Clinical Efficacy - Exdensur is the first ultra-long-acting biologic for respiratory diseases, with a dosing frequency of only twice a year [1] - Clinical trial data indicates that the drug can reduce the risk of acute exacerbations in severe asthma patients by 54% and alleviate nasal congestion symptoms in chronic sinusitis patients while reducing the size of nasal polyps [1] Group 3: Market Potential - Exdensur is considered a key component of GSK's future growth strategy [1] - The company plans to expand the drug's applications across various indications between 2026 and 2027 [1] - GSK anticipates that Exdensur could achieve annual sales of up to £3 billion (approximately $4 billion) [1] Group 4: Target Patient Population - GSK estimates that there are approximately 2 million patients with severe asthma in the United States, with half of these patients still facing frequent exacerbations and hospitalization risks [1]