Drugs to watch in 2025: will these become blockbusters?

A blockbuster drug is a therapy that generates at least $1 billion in sales. Clarivate’s Drugs to Watch 2025 report includes treatments that were approved last year or expected to debut this year and poised to become blockbusters by 2030. Here are some of the drugs that are predicted to cause a shift across various therapeutic markets.

CagriSema

Glucagon-like peptide-1 (GLP-1) agonists have gained quite a bit of traction in recent times with Novo Nordisk-owned Ozempic sales hitting 29.8 billion Danish kroner (around $4.3 billion) in the third quarter of last year. The pharma giant will continue to enjoy its hold over the GLP-1 market if its once-weekly injectable CagriSema makes it past clearance.

CagriSema is a combination of semaglutide – the active ingredient in Ozempic and Wegovy – and cagrilintide to regulate blood sugar levels and help suppress appetite. Cagrilintide is an analog of the hormone amylin, which aids in blood sugar regulation to treat type 2 diabetes and obesity. The only approved amylin analog at present is AstraZeneca’s Symlin.

In a phase 3 trial, CagriSema beat Ozempic after people on CagriSema lost 22.7% of their body weight after 68 weeks. While this was a blow to some investors since the drug was initially predicted to decrease body weight by at least 25%, the trial achieved its primary endpoint. Analysts think that the drug could erode Wegovy’s patient shares.

Awiqli

Also in Novo Nordisk’s diabetes roster is Awiqli, a long-acting insulin. Awiqli contains the active ingredient insulin icodec, which binds to a protein called albumin so that it can stay in the body for longer. What makes it stand out is that, unlike long-acting insulin treatments, which need to be administered daily, Awiqli reduces the treatment burden as it is a weekly dosage.

The drug is available in Australia, Canada, the European Union, Mainland China, and Japan. However, its entry to U.S. markets has been delayed after the drug was rejected by the U.S. Food and Drug Administration (FDA). 

It has been tested against once-daily insulin replacement therapies and showed higher reduction in blood sugar levels in several trials, however, cases of hypoglycemia – a condition in which blood sugar levels drop below normal – were recorded.

Although therapeutic development for diabetes treatment is crowded at the moment with over 150 drugs currently being evaluated in the clinic, Awiqli is likely to be welcomed as insulin replacement therapy remains the first-line of therapy to treat both forms of diabetes. Still, uncertainty over its safety may pose a barrier to it becoming a blockbuster.

Cobenfy

Last year, U.S. regulators approved the first drug for schizophrenia in decades. Bristol Myers Squibb’s (BMS’) Cobenfy – formerly known as KarXT – is now poised to become a blockbuster by 2026 with analysts expecting the drug to reap $10 billion in sales in the G7 countries, namely Canada, France, Germany, Italy, Japan, U.K., and U.S.

The drug was greenlit late last year after a long journey through drug development. One of the drug’s active ingredients, xanomeline, was first discovered by pharma giant Lilly several decades ago. Xanomeline, which is a muscarinic agonist that stimulates the muscarinic M1 and M4 receptors in the central nervous system (CNS) by crossing the blood-brain barrier, proved its cognitive benefits back in the 1990s. However, stomach-related side effects plagued its effectiveness. 

After Massachusetts-based Karuna Therapeutics bought xanomeline in 2012, it decided to combine it with trospium chloride – a drug for bladder control – which helps mitigate the side effects that xanomeline brings. A successful phase 2 trial of the combination Cobenfy more than five years ago, opened the gates for approval. BMS got its hands on the drug after its $14 billion buyout of Karuna Therapeutics after which the drug was authorized by the FDA in September. 

While other schizophrenia drugs target a dopamine receptor to treat what are known as ‘positive symptoms’ such as hallucinations and delusions, they don’t relieve ‘negative symptoms’ like depression and cognitive impairment. Cobenfy has been found to improve both positive and negative symptoms in people, which is a significant shift in schizophrenia care.  

Ebglyss

Atopic dermatitis is a chronic skin condition that affects 16.5 million people in the U.S., according to the National Eczema Association. While corticosteroids are a first-line treatment to treat flare ups, they don’t work for everyone. That’s where biologics come into the picture.

Ebglyss is the third biologic targeting IL-13 to be approved by the FDA. The monoclonal antibody lebrikizumab is designed to neutralize the IL-13 protein, which can cause inflammation of the skin. It received the FDA nod after 38% of patients in a phase 3 trial who took the drug had clear skin after 16 weeks compared to 12% in the placebo group. Among those who experienced this improvement in the treatment group, 77% saw the results last for a year.

Although Lilly’s Ebglyss most likely won’t overtake Dupixent in the biologics market as the latter has long-dominated the field at least in atopic dermatitis, Ebglyss is projected to make $6 billion in sales by 2030. As there are patients who don’t respond well to other medicines like JAK inhibitors and even biologics like Dupixent, the entry of Ebglyss into the market expands treatment options for patients. 

Fitusiran

Expected to hit $1 billion in sales by 2030 if approved, Fitusiran could be the first antithrombin-lowering therapy based on a double-stranded RNA molecule to treat hemophilia A and B.

Sanofi and Massachusetts-based Alnylam Pharmaceuticals’ Fitusiran is currently being reviewed by the FDA following a phase 3 trial, which showed that the drug cut annualized bleeding rates (ABR) – a measure of the number of bleeding events that occur within a year – significantly. In fact, in a 120-patient trial, the ABR plummeted by 89.9% in the treatment group. The drug lowers antithrombin to enhance thrombin production as it helps control bleeding.

As most FVIII and FIX – coagulation factors linked to hemophilia disorders – replacement therapies are administered once or twice a week, Fitusiran’s once-monthly dosage seeks to ease treatment burden. Plans to reduce dosage to once in two months are also in motion.

Imdelltra

Extensive-stage small cell lung cancer (E-S SCLC) is a type of lung cancer that has spread beyond the lung and lymph nodes, and is very hard to treat. Amgen’s Imdelltra is the first of its kind immunotherapy that is designed to target CD3 on T cells and DLL3 on tumor cells – expressed on more than 85% of patients. 

A 10-mg dose of the drug had an 40% objective response rate (ORR) in patients who had received a median of two lines of prior treatment, according to a phase 2 trial. This was regarded as a watershed moment and was followed by a stamp of approval from the FDA.

As Imdelltra has now debuted in the market, it is expected to cash in $2.1 billion in sales in five years. However, as it comes with a black box warning for cytokine release syndrome and neurotoxicities, many doctors may not be keen on prescribing the drug to patients, as managing these side effects isn’t easy.

mResvia 

An infection caused by the respiratory syncytial virus (RSV) can start off with flu-like symptoms such as fever, cough, shortness of breath, wheezing, and tiredness, but can quickly turn fatal if not treated, especially in vulnerable children and adults. 

Several pharmaceuticals took it upon themselves to create vaccines to prevent the spread of the disease. mRNA vaccine developer Moderna was among them and its efforts paid off last year when its RSV vaccine mResvia was signed off by the FDA in May. The vaccine works by preparing the body to defend against the virus. The mRNA vaccine contains the instructions for making the RSV-A glycoprotein F, which is present on the surface of the virus.

mResvia will compete with Abrysvo and Arexvy, which are the other RSV vaccines in the market, and is expected to enter the billion-dollar club by 2030. At present, several trials involving the vaccine are ongoing to treat different patient cohorts from infants to high-risk adults.

SEL-212

Gout is a type of arthritis that causes severe joint pain and affects around 8.3 million people in the U.S. Swedish company Sobi’s SEL-212 could offer a therapeutic approach beyond Krystexxa, which is the only drug that has been cleared to treat chronic gout in patients who don’t respond to standard treatment. 

How SEL-212 works is twofold. It contains pegadricase, a recombinant uricase enzyme, and the nanoparticle ImmTOR, which work together to reduce serum urate (SU) levels in people with chronic gout. The drug was able to do so in a phase 3 trial that led to the company filing a rolling Biologic License Application (BLA). 

The drug candidate is thought to have an edge over Krystexxa as they share similar efficacy despite SEL-212’s less frequent dosing regimen. Sales of the drug, if approved by the U.S., are set to cross $1 billion in five years.

Vepdegestrant

Protein degraders, also known as molecular glues, are molecules that bind to proteins linked to diseases to destroy diseased cells. These medicines are famed for drugging undruggable targets. Arvinas and Pfizer’s vepdegestrant belongs to this class of drugs and was awarded Fast Track Designation for the treatment of patients with ER+/HER2- breast cancer last year.

So far, it is the only protein degrader to get to the phase 3 stage for breast cancer. It is being developed as a monotherapy as well as a combination therapy along with CDK inhibitors to delay the progression of ER+/HER2- breast cancer, which accounts for 73% of breast cancers.

Thought to be the “next frontier” in breast cancer research, according to the Clarivate report, vepdegestrant could potentially make profits worth $1.19 billion by 2030.

Zanzalintinib

Another tumor killer, zanzalintinib, is an oral tyrosine kinase inhibitor. The once-daily oral pill is used to treat head and neck, squamous cell, kidney, and colorectal cancer.

Owned by California-based Exelixis, zanzalintinib was tested in a phase 1/2 study and an ORR of 38% and a disease control rate of 88% were measured in patients with clear cell renal cell carcinoma who had previously undergone treatment, after eight months.

Around a quarter of the patients with renal cell carcinoma (RCC) have non clear cell RCC, which is a population that has limited treatment options. Zanzalintinib’s possible authorization would make it the first to treat this specific indication. The drug is currently in phase 3 trials. However, generics of cabozantinib – a molecule similar to zanzalintinib – which will launch in the U.S. next year, could threaten its foreseeable blockbuster status, according to Clarivate.

2025: a year of therapeutic progress?

Some other medicines that are slated to become blockbusters in the near future include GSK’s vaccine candidate GSK-3536819 against the deadly bacteria Neisseria meningitidis, Astra Zeneca and Daiichi Sankyo’s breast cancer drug Enhertu, and Novartis’ obesity medicine Wegovy. 

As this year’s report underlines some of the key trends reshaping the life sciences landscape, Mike Ward, Global Head of Thought Leadership, Life Sciences & Healthcare at Clarivate, said: “2025 represents a turning point for the life sciences sector as it embraces cutting-edge technologies such as artificial intelligence (AI) and machine learning to enhance drug discovery and development. This year’s report captures the dynamic forces at play, including groundbreaking progress in precision oncology, the rise of radiopharmaceuticals, and the growing focus on addressing global health disparities.”