11 blockbuster drugs to look out for in 2025

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Spotlight on the results stage
Gerd Altmann

Drugs for metabolic diseases, vaccines, and cancer therapies feature among new product launches this year that could top $1 billion in annual sales or be clinical "game changers" in the next five years, according to Clarivate.

The latest edition of the company's annual Drugs to Watch list zeroes in on drugs in late-stage development or recent launches with the potential to transform treatment on a global scale, with Novo Nordisk the only drugmaker to have more than one product that made the cut. The report – which can be viewed here – highlights the following new medicines:

1) Novo Nordisk's Awiqli (LAI 287; insulin icodec), a long-acting basal insulin analogue for type 1 and type 2 diabetes that is the first drug in the class to offer once-weekly subcutaneous administration, rather than daily dosing. The drug has already been launched in Australia, Canada, the EU, mainland China, and Japan and, although it was rejected by the US FDA last year, is predicted to make $4.7 billion in sales from G7 markets (Canada, France, Germany, Italy, Japan, the UK, and the US) by 2030.

2) Novo Nordisk's CagriSema (cagrilintide and semaglutide), a fixed-dose combination of an amylin analogue and GLP-1 agonist for obesity and type 2 diabetes and successor to the company's big-selling Wegovy and Ozempic based on semaglutide monotherapy. Despite a recent data readout that disappointed investors and led to a steep decline in Novo Nordisk's share price, Clarivate is predicting G7 sales potential of $4.7 billion in obesity and $3.6 billion in diabetes.

3) Bristol Myers Squibb's Cobenfy (KarXT; xanomeline and trospium chloride), a dual M1/M4 muscarinic acetylcholine receptor agonist for schizophrenia and psychosis related to Alzheimer's disease. The drug is the first in over 30 years with a novel mechanism of action for treating schizophrenia and, while its potential in Alzheimer's remains uncertain, is tipped for sales of $1.6 billion.

4) Eli Lilly and Almirall's Ebglyss (lebrikizumab), an anti-IL-13 antibody for atopic dermatitis that offers less frequent dosing than its two predecessors in the class, Sanofi/Regeneron's Dupixent (dupilumab) and LEO Pharma's Adbry/Adtralza (tralokinumab). According to Clarivate, Ebglyss could become a first-line treatment of choice for moderate-to-severe atopic dermatitis when topical steroids are inadequate and make sales of $6 billion.

5) Sanofi and Alnylam's fitusiran, a once-monthly small interfering RNA (siRNA) therapy for haemophilia A and B that works by inhibiting SerpinPC1 mRNA, reducing antithrombin levels, promoting thrombin generation, and helping to rebalance haemostasis to prevent bleeds. According to the report, fitusiran could become the first antithrombin-lowering therapy based on a double-stranded RNA molecule, pending approval, and has a sales prediction of $1 billion.

6) GSK's GSK-3536819, a five-in-one vaccine for protecting against meningococcal disease caused by Neisseria meningitidis A, B, C W, and Y strains that are responsible for most invasive meningococcal disease (IMD) cases worldwide. The vaccine combines the antigenic components of GSK's already licensed meningococcal vaccines Bexsero (B) and Menveo (ACWY) in one shot and is expected to make $905 million from the US and the top four EU markets.

7) Amgen's Imdelltra/Imdylltra (tarlatamab), DLL3×CD3-targeting bispecific T-cell engager (BiTE) for extensive stage small cell lung cancer (ES-SCLC), the first DLL3-directed therapy to reach the market that has been approved in the US and the UK. DLL3 is an antigen with low expression in normal tissues, but is significantly overexpressed in SCLC and some other solid tumours, making it an attractive drug target. Clarivate thinks the drug could become a standard of care for previously treated SCLC and expects G7 sales to reach $2.1 billion.

8) Moderna's mResvia mRNA vaccine for protection against respiratory syncytial virus (RSV) disease in adults aged 60 and over, which was approved in the US last year as a rival to GSK's Arexvy and Pfizer's Abrysvo – both of which featured on Clarivate's 2024 list. While Moderna has said it overestimated the initial sales potential for mResvia – mainly because of a US decision to narrow the recommended use of RSV shots in older adults – Clarivate reckons it could become a $1.4 billion seller.

9) Sobi and Cartesian Therapeutics/Selecta Biosciences' SEL-212 (nanoparticle encapsulated sirolimus and pegylated uricase), a novel, once-monthly treatment for gout that could overcome the limitations of reduced efficacy and tolerability seen with other biologic treatments, including the two companies' current therapy Krystexxa (pegloticase). The report is modelling G7 sales of $1.7 billion for SEL-212, which has been filed for approval in the US.

10) Arvinas and Pfizer's vepdegestrant (ARV-471), a protein degrader targeting oestrogen receptors for breast cancer, which could become the first drug in the PROteolysis Targeting Chimera (PROTAC) class to reach the market. Clarivate says early studies suggest PROTAC-induced degradation is more complete than drugs in the oral selective estrogen receptor degraders (SERD) class like fulvestrant and could overcome endocrine resistance in breast cancer. It has a 2030 sales prediction for the drug of $1.19 billion.

11) Exelexis' zanzalintinib (XL092), a tyrosine kinase inhibitor targeting VEGF receptors, MET, and TAM kinases that is currently in phase 3 testing for colorectal cancer, renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN). It is billed as a next-generation follow-up to Exelixis and Ipsen's Cabometyx (cabozantinib), approved for RCC, with potential for broader use that could drive sales to $2.6 billion in five years if it gets approved across all three indications.

Image by Gerd Altmann from Pixabay