Novel drug therapies approved in 2025

As the year comes to an end, let us take a look at some of the new drugs approved in 2025 for the United States (US) and Indian markets.

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1. The US – new drugs approved by the US Food and Drug Administration (FDA)

‘Novel’ drugs are drugs that have never been approved for the US market before. As of the 24^th of December, this year, 44 novel drugs have been approved for the US market, spanning multiple therapeutic areas including oncology, cardiology, immunology, infectious disease, and rare diseases.

Here is a selective list of new drugs approved by the US FDA.

Drug Name (Active Ingredient)	Type	US FDA-approved uses	Mechanism
Journavx (suzetrigine)	Non-opioid analgesic	Moderate to severe acute pain in adults	Blocks pain signals (sodium channels) in the peripheral nervous system  before they reach the brain
Blujepa (gepotidacin)	Triazaacenaphthylene antibiotic	Uncomplicated urinary tract infections in female patients ≥12 y of age weighing ≥40 kg	Targets & blocks bacterial enzymes essential for DNA replication, which kills the bacteria
Qfitlia (fitusiran)	Small interfering RNA (siRNA) therapy	Prophylactic care for hemophilia A & hemophilia B in patients ≥12y	Reduces the production of antithrombin, a protein that inhibits blood clotting, increasing thrombin
Keytruda Qlex (pembrolizumab & perahyaluronidase alfa-pmph)	PD-1 inhibitor and monoclonal antibody	Adult & pediatric (≥12y) solid tumors	Activates the immune system, allowing T-cells to detect and attack cancer cells
Cardamyst (etripamil)	Self-administered nasal spray	Paroxysmal supraventricular tachycardia	Blocks L-type calcium channels in the heart, which interrupts abnormal heart rhythm and restores normal heartbeat
Voyxact (sibeprenlimab-szsi)	Monoclonal antibody	Adults with primary immunoglobulin A nephropathy (IgAN) to reduce proteinuria and kidney damage	Binds to A Proliferation-Inducing Ligand (APRIL) & blocks signaling receptors, to reduce levels of pathogenic immunoglobulin A1 (IgA1)
Redemplo (plozasiran)	Small interfering RNA (siRNA) therapy	Reduce triglycerides in adults with chylomicronemia syndrome	Targets & degrades the apoC-III mRNA by RNA interference mechanism, resulting in reduced levels of hepatic & serum apoC-III protein.
Brinsupri (brensocatib)	DPP1 inhibitor	Non-cystic fibrosis bronchiectasis in  patients ≥12y	Blocks DPP1, which prevents activation of pro-inflammatory enzymes in neutrophils. This slows down the progression of lung infection.
Dawnzera (donidalorsen)	RNA-targeted therapy (prekallikrein-directed antisense oligonucleotide)	To avert attacks of hereditary angioedema	Targets and reduces the production of prekallikrein protein in the liver that prevents excessive formation of bradykinin
Komzifti (ziftomenib)	Menin inhibitor	Relapsed or refractory acute myeloid leukemia with susceptible nucleophosmin 1 mutation in adults	Blocks the interaction of menin and lysin [K]-specific methyltransferase 2A

 

India – New drugs approved by the Central Drugs Standard Control Organization (CDSCO)

Here are some new drugs that have been approved by the CDSCO, India, in 2025 :

Drug Name	Type	CDSCO-approved uses	Mechanism
Letermovir	Antiviral (Quinazoline Derivative)	Prevention of cytomegalovirus infection and disease in adult seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) or adult recipients of kidney transplant	Disrupts the process of cleaving and packaging viral DNA into mature virus particles.
Edoxaban	Oral anticoagulant (DOAC)	· Prevention of stroke & systemic embolism in adult patients with nonvalvular atrial fibrillation with ≥1 risk factor, such as congestive heart failure, hypertension, age ≥ 75y, diabetes mellitus, prior stroke or transient ischemic attack(TIA). · Treatment of deep vein thrombosis (DVT) & pulmonary embolism (PE), and · Prevention of recurrent DVT & PE in adults	Blocks clotting protein Factor Xa in blood, to reduce the risk of clot formation.
Sodium zirconium cyclosilicate powder for oral suspension 5g/10g	Inorganic, selective monovalent cation exchanger	Hyperkalemia in adults	Binds potassium ions in the gastrointestinal tract, which are removed from the body in stool
Rimegepant	Calcitonin gene-related peptide (CGRP) receptor antagonist	Acute & episodic migraine with/without aura in adults with a previous insufficient response to triptans	Blocks the CGRP receptor to stop the release of pain-inducing signals and vasodilation associated with migraines
Doravirine	Antiretroviral [non-nucleoside reverse transcriptase inhibitor (NNRTI)]	In combination with other antiretroviral agents to treat HIV-1 infection in treatment-naïve patients ≥35 kg	Blocks activity of HIV-1 reverse transcriptase (RT) enzyme to stop replication of the virus
Tucatinib	Tyrosine kinase inhibitor (TKI)	In combination with trastuzumab &  capecitabine, for adults with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received ≥1 prior anti-HER2-based regimens in the metastatic setting	Blocks signals from the HER2-positive protein inside cancer cells and stops tumor growth
Zanubrutinib	Bruton's tyrosine kinase (BTK) inhibitor	Adults with different types of B-cell malignancies	Irreversibly inhibits the BTK enzyme in the B-cell receptor signaling, which halts B-cell proliferation and leads to tumor cell death
Linaclotide	Synthetic 14-amino acid peptide	Chronic idiopathic constipation (CIC) in adults	Binds to GC-C receptors on intestinal epithelial cells, which promotes the secretion of chloride and bicarbonate ions and inhibits sodium absorption. This leads to increased fluid and relieves constipation.
Ivosidenib	Small-molecule inhibitor and an enzyme inhibitor	Newly diagnosed acute myelogenous leukemia & advanced or metastatic cholangiocarcinoma with isocitrate dehydrogenase-1 (IDH1) R132 mutation in adults	Inhibits mutant IDH-1, which reduces cancer-promoting 2-HG and restores normal cell differentiation
Datopotamab deruxtecan	Antibody-drug conjugate (ADC)	Unresectable or metastatic HR+ve, HER2-ve breast cancer cases who have received prior endocrine-based therapy and chemotherapy	Delivers topoisomerase I inhibitor directly to cancer cells, causing DNA damage, blocking replication and leading to apoptosis
Fexuprazan hydrochloride	Potassium-competitive acid blocker (P-CAB)	Erosive esophagitis	Reversibly blocks the H+/K+ ATPase enzyme (proton pump) in parietal cells of the stomach

 

Take a moment to thank all the participants in clinical trials, who made it possible for newer drugs to be available this year...the regulators, companies that sponsored these trials, the ethics committees, the investigators and site staff, and overall the participants/patients who agreed to have a new drug tested on them. 

The memory bridge: Caring for mind, caring for future

 

Trainee Medical Writer, Natasha Das MedComm

“Memory is the diary we all carry about with us.” — Oscar Wilde.

But what happens when the pages of that diary begin to fade? 

On World Alzheimer’s Day, we pause to reflect not only on the science of memory loss but also on its profound impact on families, communities and the stories that shape us.

For many families, Alzheimer’s is not an abstract medical term, it is the grandmother who no longer recalls her wedding day or the father who forgets his daughter’s name. Behind the medical statistics are millions of stories of resilience, heartbreak, and love.

What is Alzheimer’s really about?

Alzheimer’s disease is not just normal aging. Occasional forgetfulness happens to everyone, losing keys, misplacing glasses, or forgetting a name for a moment. But Alzheimer’s is different. It is a progressive brain disorder that damages memory, thinking, and behavior to the point where daily life becomes difficult. It accounts for 60–70% of all dementia cases worldwide [1].

Think of the brain as a bustling city. In Alzheimer’s, the roads (nerve connections) get blocked by plaques and tangles, slowing signals. Amyloid plaques are sticky clumps of protein that interrupt cell communication. Tau tangles are abnormal accumulation of the protein tau that form inside brain cells and  disrupt transport of essential nutrients within brain cells [2]. Over time, entire neighborhoods - memories, language, reasoning grow dark.

But Alzheimer’s is more than biology. It is a disease that tests human relationships, patience, and endurance. Families often say they feel like they lose their loved ones twice, once to the disease and then to age.

Why should younger people care?

It’s easy to think Alzheimer’s is an old person’s disease, but brain health is a lifelong investment. Habits we build today from diet to sleep to stress management play a role in keeping the brain resilient tomorrow.

So, when we talk about Alzheimer’s, we aren’t just talking about their future. We are talking about ours as well.

Risk factors you can’t ignore

The greatest risk factor is age. Most people diagnosed are over 65. But aging alone does not cause Alzheimer’s. Genetics also play a role, certain variants, like the APOE ε4 gene, increases the risk of developing the disease [3].

Lifestyle and environment also significantly influence the risk of developing Alzheimer’s disease. Conditions such as high blood pressure, diabetes, obesity, depression, and smoking are linked with higher chances of dementia [4]. In fact, a Lancet Commission report estimated that addressing modifiable risk factors could prevent or delay up to 40% of dementia cases worldwide [5].

This means that while we cannot change our genes, we can change our choices.

Building a brain-healthy life

“What’s good for the heart is good for the head.”

The same habits that protect our hearts also protect our brains. Research shows that:

●     Movement matters – Regular physical activity improves blood flow, reduces inflammation, and boosts brain resilience [5]. Even walking, dancing, or gardening can help.

●     Food fuels memory – Diets rich in leafy greens, berries, olive oil, nuts and fish are linked with slower cognitive decline [7].

●     Sleep clears the brain – Deep sleep helps flush out toxic proteins like amyloid. Chronic sleep deprivation increases Alzheimer’s risk [8].

●     Challenge the mind – Reading, solving puzzles, learning a language, or even playing an instrument builds cognitive reserve, giving the brain backup strength [9].

●     Stay connected – Social interaction is a powerful buffer against dementia. Conversations, friendships, and community activities stimulate memory and lift mood [4].

●     Prioritize oral health – Regular dental care reduces inflammation that can help lower the burden on the brain.

In simple words: move, eat well, rest, learn, and connect.

For families and caregivers

Alzheimer’s does not just affect individuals; it reshapes entire families. Caregivers often face exhaustion, guilt, and grief. The CDC highlights the need for support systems, caregiver education, and counseling [4].Just as patients deserve dignity, caregivers deserve compassion and rest.

One of the most important steps is early diagnosis. Detecting Alzheimer’s in its early stages allows for better management, planning, and support. Memory clinics, cognitive screening, and timely medical guidance can make a significant difference.

A collective responsibility

Alzheimer’s is not just a medical challenge; it is a societal one. With population aging, the numbers are rising sharply. The WHO projects that by 2050, the number of people living with dementia could reach 139 million globally [10]. Without awareness and preventive action, health systems may struggle to cope.

World Alzheimer’s Day reminds us that awareness is the seed of change. If younger generations adopt brain-healthy habits today, the burden tomorrow may be lighter. If families and communities speak openly about dementia, the stigma begins to fade. If we listen with patience and care, we give dignity to those whose words may falter.

Closing thought

Alzheimer’s is often called the long goodbye. Yet, within that long journey, lies a profound truth. While memories may fade, emotions remain. A person with Alzheimer’s may forget a name but still feel the warmth of a hug, the joy of music, or the comfort of kindness.

On this World Alzheimer’s Day, let us promise two things - to protect our own brain health and to stand beside those who cannot fight alone. Because in the end, every memory matters, and every person deserves to be remembered with love.

References

1. Alzheimer’s Association. Alzheimer’s disease facts and figures. Alzheimers Dement. 2024.
2. Mayo Clinic. Alzheimer’s disease – Symptoms and causes. Mayo Clinic; 2024.
3. National Institute on Aging. Alzheimer’s Disease Genetics Fact Sheet. NIH; 2022.
4. Centers for Disease Control and Prevention. What is Alzheimer’s Disease? CDC; 2023.
5. Livingston G, et al. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020;396(10248):413–446.
6. Kamer AR, et al. Periodontal disease and risk of dementia. Journal of the American Geriatrics Society. 2020.
7. Morris MC, et al. MIND diet associated with reduced incidence of Alzheimer’s disease. Alzheimers Dement. 2015;11(9):1007–1014.
8. Spira AP, et al. Self-reported sleep and β-amyloid deposition in community-dwelling older adults. JAMA Neurol. 2013;70(12):1537–1543.
9. Stern Y. Cognitive reserve in ageing and Alzheimer’s disease. Lancet Neurol. 2012;11(11):1006–1012.
10. World Health Organization. Dementia fact sheet. WHO; 2023.