Skip to main content
The Checkout

10 new drugs expected to make waves in 2025

These upcoming FDA approvals could mean advanced treatment options and improved quality of care for patients with various medical conditions
Gerardo Sison medical writer headshot
By | Updated on Jan. 9, 2025
different medications - upcoming fda approvals

Key takeaways

  • The drug development pipeline for 2025 looks promising, with several new medications expected to gain approval this year.

  • These upcoming treatments may help tackle a range of health issues.

  • Some notable treatments include new cancer drugs and potential breakthroughs for chronic pain and hemophilia.

In this article:

The drug development pipeline for 2025 looks promising, with several new medications set to hit pharmacy shelves. These upcoming treatments may help tackle a range of health issues, from cancer to rare genetic disorders. Some notable drugs to watch include new cancer treatments like ivonescimab for non-small cell lung cancer and potential breakthroughs for chronic pain and hemophilia.

As artificial intelligence increasingly influences drug development, pharmacists may see faster rollouts of personalized treatments. This shift could mean more tailored dosing and better drug safety profiles for patients. 

10 potential upcoming FDA approvals for 2025

Read on for some of the newest drugs that could transform patient care and improve health outcomes in the coming years.

Ivonescimab for PD-L1 positive NSCLC

Ivonescimab is making waves as a promising new treatment for PD-L1 positive non-small cell lung cancer (NSCLC). This drug has shown noteworthy results in clinical trials, outperforming the current standard of care, pembrolizumab. In a recent phase 3 study, ivonescimab reduced the risk of disease progression or death by 49% compared to pembrolizumab.

The drug is expected to seek FDA approval in 2025. Its distinct mechanism of action involves dual targeting of both PD-1 and VEGF pathways to attack cancer cells. In addition, strong clinical results make it a particularly attractive option in lung cancer treatment.

CagriSema for obesity

CagriSema is a new weight-loss drug that’s getting a lot of attention. It combines two active ingredients—semaglutide (found in Ozempic) and cagrilintide—and is expected to be more powerful than current obesity treatments.

Novo Nordisk, the company behind CagriSema, plans to finish important clinical trials soon. Results from one large study are due by the end of 2024, with another coming in early 2025. If these go well, CagriSema could hit the market in late 2025. Early tests show it might help people lose up to 25% of their body weight, which is pretty impressive. This new drug could be an advanced option for treating obesity.

Suzetrigine for moderate-to-severe acute pain

Suzetrigine is set to shake up pain management in 2025. The FDA has given it priority review, with a target action date of January 30, 2025. This new drug works by blocking sodium channels in nerve cells, offering a new method to manage pain.

What’s exciting is that suzetrigine could be the first new class of acute pain medicine in over 20 years. It’s shown promise in clinical trials, with positive results in three Phase 3 studies and two Phase 2 studies for moderate-to-severe acute pain. The drug has also been well-tolerated by patients, which is a plus.

Enhertu for HER2-low or HER2-ultralow metastatic breast cancer

Enhertu (trastuzumab deruxtecan) is making waves in breast cancer treatment. It’s under Priority Review by the FDA for patients with HER2-low or HER2-ultralow metastatic breast cancer who’ve had at least one round of endocrine therapy. This drug is a big deal because it targets cancers that were tough to treat before.

Enhertu works by delivering cancer-killing drugs right to the tumor cells. In a recent study, it showed remarkable results, keeping cancer at bay for about 13 months in patients with HR-positive, HER2-low metastatic breast cancer. That’s a lot better than standard chemo. With potential FDA approval on the horizon, Enhertu could be a useful option for many breast cancer patients in 2025.

Fitusiran for hemophilia

Fitusiran is a new drug that might change how we treat hemophilia A and B. The FDA is considering its approval, which may be decided by March 28, 2025. This drug works for both types of hemophilia, even in people with inhibitors.

Sanofi, the company making fitusiran, says it’s given as a shot under the skin once a month. In a large study, people who got fitusiran had fewer bleeding episodes than those using other treatments. The average was just 1.7 bleeds per year. This could be great news for people with hemophilia who want an easier way to manage their condition.

Sebetralstat for hereditary angioedema (HAE) attacks

Sebetralstat is a new oral drug that’s expected to change how hereditary angioedema (HAE) attacks are treated. It’s taken as needed when an attack starts, offering a more convenient option than current injected or infused treatments. The FDA might approve it in June 2025, which would be exciting news for HAE patients.

This drug works by blocking plasma kallikrein, a key factor in HAE attacks. In a recent study, sebetralstat helped people feel better faster than a placebo. The 300 mg and 600 mg doses both worked well, giving quick relief from HAE symptoms. This drug is appealing because it could let people treat attacks at home without needles.

Cardamyst for PSVT

Cardamyst (etripamil) is a promising new drug for treating paroxysmal supraventricular tachycardia (PSVT). The FDA is reviewing the New Drug Application for Cardamyst, with a target decision date of March 27, 2025. This nasal spray could offer PSVT patients a quick and easy way to manage their symptoms at home.

Positive results from the pivotal Phase 3 RAPID trial demonstrated that etripamil, the active ingredient in Cardamyst, was twice as effective and three times as fast as a placebo in restoring normal heart rhythm. Specifically, 64.3% of etripamil patients experienced PSVT termination within 30 minutes compared with 31.2% of placebo patients. Milestone Pharmaceuticals is the company behind Cardamyst.

Moderna’s combined COVID-19 and flu vaccine

Moderna’s new combo shot could make getting yearly vaccines much easier. The company has created a single vaccine that protects against both COVID-19 and the flu. If it gets FDA approval, this 2-in-1 jab might hit pharmacies in 2025.

In the Phase 3 study, the combo vaccine worked better than getting separate flu and COVID shots. It sparked a stronger immune response in adults over 50. The vaccine uses mRNA technology, which helps the body make its virus-fighting proteins. A combined vaccine could be a helpful option for busy folks who don’t want to schedule multiple vaccine appointments.

Sunlenca for long-acting HIV prevention treatment

Sunlenca (lenacapavir) is a promising new drug for HIV prevention. It’s a twice-yearly injection that could be a game-changer for people who struggle with daily pills. In a recent trial, Sunlenca was 96% effective in preventing HIV infection.

The FDA might approve Sunlenca for HIV prevention by 2025. It’s already approved for treating HIV in some people. This drug works differently from other HIV meds. It’s a capsid inhibitor, which means it stops the virus from making copies of itself. For people who can’t or prefer not to take daily pills, Sunlenca could be a great option to stay HIV-negative.

Ozempic for chronic kidney disease

Ozempic (semaglutide) might soon be used to treat chronic kidney disease in people with Type 2 diabetes. This popular diabetes drug has shown promise in slowing kidney disease progression.

A recent study found that Ozempic reduced the risk of kidney complications and heart issues in people with Type 2 diabetes and chronic kidney disease. The drug cut the risk of kidney disease-related events by 24% compared to a placebo. Ozempic works by mimicking a hormone that regulates blood sugar and appetite. The FDA is now reviewing an application to expand Ozempic’s use for kidney disease. If approved, it could offer a new treatment option for millions of people with this condition.

Zepbound for obstructive sleep apnea

Zepbound (tirzepatide) might soon help people with sleep apnea breathe easier at night. Eli Lilly expects the FDA to decide on approving this drug for obstructive sleep apnea by early 2025. This is big news because Zepbound works differently than current sleep apnea treatments. It helps people lose weight, which may, in turn, help improve breathing during sleep.

Recent studies have shown promising results for Zepbound. It effectively resolved sleep apnea, reducing the Apnea-Hypopnea Index (AHI) by 20.0 events per hour in trial 1 and 23.8 events per hour in trial 2. This drug could be a useful treatment for those struggling with both obesity and sleep apnea, as it provides a new way to manage these linked health issues with just one medication.

Looking ahead

The year 2025 is set to be noteworthy for new drug approvals, with many innovative medicines in development. Key focus areas include cancer treatments, pain management, heart disease therapies, and rare disease drugs. Suzetrigine, in particular, could revolutionize pain management, while other medications like Ozempic are being explored for new potential uses, such as managing chronic kidney disease. While the FDA’s thorough approval process can take years, it can ultimately bring new treatment options for patients and healthcare providers alike.

Sources