What new products, recently or expected to launch in 2025, show blockbuster potential, and do their prospects still remain bright? DCAT Value Chain Insights takes an inside look at the companies & bio/pharmaceuticals rising to the top of the class.

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

Plotting the path of potential blockbusters
Each year brings the promise of new market entrants, and a January 2025 analysis by Clarivate, a business intelligence firm, in its 2025 Drugs To Watch report, identified 11 new-to-market products with projected 2025 launch or newly launched with potential blockbuster/near blockbuster status (defined as sales of $1 billion or more) by 2030. As we progress in 2025, where do these products now stand?

On top of the list of the 11 drugs, based on projected sales in 2030 was Eli Lilly and Company’s and Amirall’s Ebglyss (lebrikizumab) for treating atopic dermatitis (eczema). Novo Nordisk placed with two projected blockbusters: Awiqli (basal insulin icodec) for treating diabetes and CagriSema (cagrilintide and semaglutide), a combination therapy and follow-on to its blockbuster Type 2 diabetes and obesity drugs, Ozempic/Wegovy (semaglutide). Other top contenders by the large biotech/pharma companies, either developed singularly or in partnership, included: Bristol-Myers Squibb’s Cobenfy (xanomeline and trospium) for treating schizophrenia; Amgen’s Imdelltra (tarlatamab-dlle) for treating extensive small-cell lung cancer; Sanofi’s and Alnylam Pharmaceuticals’ Qfitlia (fitusiran) for treating hemophilia A and B; GSK’s Neisseria meningitidis (A, B, C, W, and Y) vaccine; and Pfizer’s/Arvinas’ vepdegestrant for treating a certain form of advanced breast cancer. Other contenders from mid-sized to smaller companies included Moderna’s mResvia (respiratory syncytial virus vaccine); Exelixis’ zanzalintinib for treating multiple cancers; and Sobi’s NASP (nano-encapsulated sirolimus plus pegadricase) for treating chronic gout.

Novo Nordisk’s Awiqli (basal insulin icodec). Novo Nordisk’s Awiqli (basal insulin icodec) for treating Type 1 and Type 2 diabetes mellitus, the first once-weekly, subcutaneous insulin, offers potential advantages over daily basal insulin by reducing frequency of injections for the long-acting insulin from daily to weekly injections. The drug has been approved in Australia, Canada, the European Union, Mainland China and Japan, but approval and launch in the US was delayed due to the company receiving a Complete Response Letter (CRL) in July 2024 by the US Food and Drug Administration (FDA). At the time of receiving the CRL in July 2024, Novo Nordisk said that FDA had requested information related to the manufacturing process and the Type 1 diabetes indication before the review of the application could be completed. The CRL followed a meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee in May 2024, which concluded that the data available at that time were not sufficient to conclude a positive benefit-risk in Type 1 diabetes. The Advisory Committee did not discuss the use of once-weekly insulin icodec in Type 2 diabetes. Review in the US is still pending.

The therapeutic pipeline for Type 2 diabetes is extremely crowded, with more than 150 drugs in active clinical development, according to information from Clarivate. In addition, glucagon-like peptide-1 receptor agonists (GLP-1 Ras) are dominating the Phase III pipeline and include more convenient oral options (e.g., Eli Lilly and Company’s orforglipron), GLP-1 combination therapies (e.g., Novo Nordisk’s IcoSema (insulin icodec and semaglutide), and Novo Nordisk’s CagriSema (cagrilintide and semaglutide), and other insulin analogs (Lilly’s insulin efsitora alfa).

Novo Nordisk’s CagriSema (cagrilintide and semaglutide). Novo Nordisk’s CagriSema (cagrilintide and semaglutide) is a combination therapy for treating Type 2 diabetes and obesity. It contains the same active ingredient, semaglutide, found in Novo’s Type 2 diabetes and obesity treatments, Ozempic and Wegovy, with the addition of cagrilintide, a long-acting amylin analog. It would compete over Novo’s GLP-1 agonists, Ozempic/Wegovy, and Lilly’s GLP-1 agonists, Mounjaro/Zepbound (tirzepatide) in treating obesity and Type 2 diabetes. It leverages the benefits of GLP-1s, such as enhanced insulin secretion and appetite reduction while incorporating amylin’s effects, including slowed glucose absorption and release, according to the Clarivate report. CagriSema is in Phase III of its clinical development program for treating adults with obesity and Type 2 diabetes. If approved, CagriSema will be the first fixed-dose combination of amylin and GLP-1 receptor agonists in the obesity and Type 2 diabetes markets.

Bristol-Myers Squibb’s Cobenfy (xanomeline and trospium). Bristol-Myers Squibb’s Cobenfy (xanomeline and trospium) was approved by FDA in September 2024 as a monotherapy for treating schizophrenia, marking the first antipsychotic drug to treat schizophrenia that targets cholinergic receptors, a novel mechanism of action, instead of dopamine receptors, which has been the standard of care. The drug is being evaluated cross multiple neuropsychiatric conditions, including symptoms associated with Alzheimer’s disease and autism spectrum disorder, bipolar disorder, and other areas of clinical need. While further data are needed to assess the drug’s effectiveness in Alzheimer’s disease-related psychosis, the addition of that indication would potentially add further strong commercial potential.

One further note in terms of additional clinical development for the drug is its use as an adjunctive therapy for schizophrenia in atypical antipsychotics. In April (April 2025), the company announced topline results from a Phase III trial evaluating the efficacy and safety of Cobenfy as an adjunctive treatment to atypical antipsychotics in adults with inadequately controlled symptoms of schizophrenia. The company reported that Cobenfy did not demonstrate a statistically significant improvement as an adjunctive treatment in this trial, but did show improvement for the majority of patients in the trial, as well as a tolerable safety profile, and it will further evaluate the results from this study.

Eli Lilly and Company’s and Amirall’s Ebglyss (lebrikizumab). Lilly’s and Amirall’s Ebglyss (lebrikizumab) is the third biologic for treating atopic dermatitis (eczema) that targets the interleukin-13 (IL-13) pathway, considered important in addressing inflammatory diseases, such as atopic dermatitis. The other two IL-13 biologics for treating atopic dermatitis are Sanofi’s Dupixent (dupilumab) and Leo Pharma’s Adbry/Adtralza (tralokinumab). Ebglyss’ less-frequent dosing, more selective IL-13 inhibition, and strong efficacy and safety data position it as a likely first-line treatment for moderate-to-severe atopic dermatitis when topical corticosteroids are inadequate, according to Clarivate. The drug was approved by FDA in September 2024.

Sanofi’s and Alnylam Pharmaceuticals’ Qfitlia (fitusiran). Sanofi’s and Alnylam Pharmaceuticals’ Qfitlia (fitusiran) is a RNAi therapeutic for treating hemophilia A and B, with or without inhibitors. It was developed as part of an RNAi therapeutics rare-disease alliance between Sanofi and Alnylam Pharmaceuticals. The drug received FDA approval earlier this year (March 2025) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors (neutralizing antibodies).

This small interfering RNA (siRNA) therapy works by inhibiting SerpinPC1 mRNA, reducing antithrombin levels, promoting thrombin generation, and helping to rebalance hemostasis to prevent bleeds and leverages Alnylam’s ESC-GalNAc conjugate technology, according to Clarivate. It is an antithrombin-lowering therapy based on a double-stranded RNA molecule, pending approval.

GSK’s Penmenvy (Meningococcal Groups A, B, C, W, and Y vaccine) GSK’s Neisseria meningitidis (A, B, C, W, and Y) vaccine, Penmenvy, is a five-in-one, first-generation formulation that targets the five groups of Neisseria meningitidis (A, B, C, W, and Y), which is responsible for the most invasive meningococcal disease cases worldwide. It combines the antigenic components of GSK’s licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY), both of which have established efficacy and safety profiles. It was approved by FDA in February (February 2025).

Amgen’s Imdelltra (tarlatamab-dlle). Amgen’s Imdelltra (tarlatamab-dlle) is a first-in-class immunotherapy for extensive-stage small cell lung cancer (ES-SCLC.). The drug was granted accelerated approval by FDA in May 2024 and was given orphan drug and breakthrough drug designation. The drug uses Amgen’s proprietary bispecific T cell engager (BiTE) molecules and targets CD3 on T cells and DLL3 on tumor cells, enabling T cells to attack and lyse the tumor. DLL3 is expressed on the surface of small-cell lung cancer cells in more than 85% of patients but is minimally expressed on healthy cells, thereby making it an attractive target, according to Clarivate. This mechanism positions it as a potential standard of care for previously treated ES-SCLC.

Moderna’s mRESVIA (respiratory syncytial virus vaccine). Moderna’s mRESVIA (respiratory syncytial virus [RSV] vaccine) was approved by FDA in May 2024 and joined two RSV vaccines, which made Clarivate’s Drug to Watch list in 2024, GSK’s Arexvy and Pfizer’s Abrysvo. Moderna’s RSV vaccine for adults aged 60 years and older is approved in approximately 40 countries. Additionally, Moderna recently announced that FDA approved the vaccine for the prevention of lower respiratory tract disease caused by RSV in individuals 18-59 years of age who are at increased risk for disease. Thus far, Moderna reported negligible mRESVIA sales in the second quarter of 2025.

Sobi’s NASP (nano-encapsulated sirolimus plus pegadricase). Swedish Orphan Biovitrum’s (Sobi’s) NASP (nano-encapsulated sirolimus plus pegadricase (formerly SEL-212) offers potential advantages in the treatment of gout. It is a investigational combination medicine designed to reduce serum urate levels in people with chronic refractory gout, potentially reducing harmful tissue urate deposits, which can lead to gout flares and joint deformity when left untreated. Sobi licensed SEL-212 from Selecta Biosciences (which later merged with Cartesian Therapeutics) in June 2020 and is responsible for development, regulatory and commercial activities in all markets outside of China. In June (June 2025), Sobi completed the rolling submission for a biologics license application to FDA for NASP for the treatment of uncontrolled gout. It is a once-monthly treatment combining pegylated uricase (pegadricase) with ImmTOR, an immune tolerance technology designed to inhibit formation of anti-drug antibodies (ADAs). For this application, ImmTOR consists of an inhibitor of uricase-specific ADA. This approach may help overcome the limitations of reduced efficacy and tolerability seen with other biologic treatments, such as Amgen’s Krystexxa  (pegloticase) for treating chronic gout.

Pfizer’s/Arvinas’ vepdegestrant. Pfizer’s/Arvinas’ vepdegestrant is an investigational oral medication designed to treat estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) advanced breast cancer. If approved, it would become the first PROteolysis Targeting Chimera (PROTAC) protein degrader on the market. Designed to target and degrade the estrogen receptor protein, early studies suggest PROTAC-induced degradation is more complete than with oral selective estrogen receptor degraders, thereby potentially overcoming endocrine resistance in breast cancer. Potential label expansions include the drug in combination with another breast cancer drug by Pfizer, Ibrance (palbociclib). Last month (August 2025), FDA accepted the new drug application for vepdegestrant for the treatment of patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer who have previously received endocrine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026.

Exelixis’ zanzalintinib. Exelixis’ zanzalintinib is being explored in multiple cancers and is an oral tyrosine kinase inhibitor targeting VEGF receptors, MET, and TAM kinases involved in tumor growth and immunosuppression. In June (June 2025), Exelixis announced several updates to the zanzalintinib development program. In May (May 2025), it completed enrollment in a Phase III trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced cancer (non-clear-cell renal cell carcinoma. Top-line results are expected in the first half of 2026, depending on study event rates. The company also initiated a Phase III trial evaluating zanzalintinib versus everolimus as an oral therapy in patients with advanced advanced neuroendocrine tumors, regardless of site of origin. One indication, however, the company decided not to continue development was in head and neck cancer. In June (June 2025), based on the company’s evaluation of emerging data from a Phase II trial, competition in this indication, and assessment of other, potentially larger, commercial opportunities, Exelixis decided not to proceed to Phase III studies in head and neck cancer for the drug.