Servier India receives marketing authorization for Vorasidenib (Voranigo®), for use in patients with Grade 2 IDH-mutant glioma (brain cancer)
▪ Vorasidenib is a targeted IDH inhibitor and is now approved in India.
▪ Vorasidenib received the prestigious 2025 Prix Galien USA Award for Best Product for Orphan/Rare Diseases, recognizing its scientific contribution in the field of rare diseases.
Mumbai, India | Date – 10 December 2025: Servier India, a subsidiary of the French pharmaceutical group Servier, has received marketing authorization from the Central Drugs Standard Control Organisation (CDSCO) for Vorasidenib (Voranigo®). This first-in-class, oral therapy is approved for adults and pediatric patients aged 12 years and older with Grade 2 gliomas – types of brain cancer (astrocytoma or oligodendroglioma) – with an IDH1 or IDH2 mutation, following surgery—whether biopsy, subtotal resection, or gross total resection.
Unlike conventional chemotherapy or radiotherapy, which affects both healthy and cancerous cells, Vorasidenib is a targeted therapy that inhibits the mutant IDH enzyme responsible for tumor growth and spread. This selective mechanism not only delays tumour progression but also helps patients maintain quality of life, representing a major step forward in the management of brain cancers.
The burden of these rare IDH mutated Grade 2 Gliomas is estimated to be about 4,500 patients, per year in India, with most being young adults1. For more than 20 years, patients with these cancers have lacked new and precision based therapeutic options, highlighting an unmet medical need.
Aurelien Breton, Managing Director, Servier India, said, “India is a key part of Servier’s global journey in advancing cancer care. Vorasidenib, marks a significant breakthrough directly addressing a critical unmet need in rare neuro-oncology. Alongside this, Tibsovo®, our targeted therapy for IDH1-mutated Acute Myeloid Leukemia and Cholangiocarcinoma, is available for patients — further expanding access to precision oncology treatments across India. With the introduction of such innovative therapies, we continue to work towards improving patient outcomes throughout India”
“Our team is proud to achieve this important regulatory milestone for Vorasidenib in India,” said Anagha Padhye, Director-Regulatory Affairs and Pharmacovigilance, Servier India. “This approval enables the availability of a therapeutic option for patients with Grade 2 IDH-mutant glioma and we remain committed to working closely with health authorities to ensure Voranigo’s timely access.”
“Vorasidenib exemplifies the promise of precision medicine, offering patients a treatment that targets specific genetic mutations affecting typically young adults. The treatment has the potential to help preserve their quality of life—allowing patients spend more meaningful time with loved ones. We remain committed to collaborating with the medical community through scientific exchange and education in the field of neuro-oncology.” Said Dr. Pranav Sopory, Medical and Patient Affairs Director, Servier India.
Pratima Tripathi – Commercial Director, Oncology, Servier India, added, “The introduction of Vorasidenib accelerates Servier’s impact in India’s oncology market, expanding our portfolio of innovative therapies. Building on the success of our launches earlier this year, we will continue to support scientific awareness and responsible dissemination of information to healthcare professionals.”
Globally, Voranigo® (Vorasidenib) has been recognised for its scientific excellence, having received The Galien Foundation’s 2025 Prix Galien USA Award for Best Product for Orphan/Rare Diseases, The Prix Galien Award is the world’s highest independent distinction that awards the most critical products introduced in the public market and acknowledges the achievements of the best research teams in the pharmaceutical, biotechnology, medical technology, and digital health industries. It is regarded as the equivalent of the Nobel Prize in biopharmaceutical research.
About Servier India
Servier India is an innovative healthcare company committed to transforming lives by delivering advanced, high-quality medicines that address evolving patient needs and drive impactful health outcomes. With a strong presence for around four decades in India, our focus spans several key therapeutic areas – cardiometabolism, venous diseases and oncology.
As part of Servier group operating in around 140 countries, Servier India inherits a rich legacy of scientific excellence and patient-centric innovation. Globally, Servier invests heavily in research and development, focusing on our key therapeutic areas.
Servier India contributes to the Group’s global mission by supporting scientific collaboration and responsible access to approved therapies.
About Glioma2
Gliomas are the most common type of malignant brain tumor in adults. They develop from brain support cells called glial cells. A patient’s prognosis and treatment options depend largely on whether their tumor has specific mutations in the IDH genes (IDH1 or IDH2). Testing for these mutations is therefore essential for proper diagnosis and treatment planning.”As of 2021, adult-type diffuse gliomas are sub-divided into only three categories:
▪ Astrocytoma, IDH-mutant (CNS WHO grades 2-4)
▪ Oligodendroglioma, IDH-mutant and1p19q-codeleted (CNS WHO grades 2-3)
▪ Glioblastoma, IDH-wildtype (CNS WHO grade 4)
About Servier
Servier is a global pharmaceutical group governed by a Foundation that aspires to serve its vocation with a long-term vision: being committed to therapeutic progress to serve patient needs. As a world leader in cardiometabolism and venous diseases, Servier’s ambition is to become a focused and innovative player in oncology by targeting rare cancers. Headquartered in France, Servier relies on a strong geographical footprint; its medicines are available in close to 140 countries. The group achieved a revenue of €5.9 billion in 2024.
Press contacts
Priya Panwekar
Email: priya.panwekar@servier.com
Tel: +91 70456 54080
Mandatory Disclaimer
Disclaimer: This press release is intended solely to communicate factual information regarding a regulatory approval. Any reference to Vorasidenib (Voranigo®) is for informational purposes only and does not constitute advertising, promotion, or an inducement to prescribe, purchase, or use the product. All treatment decisions must be made exclusively by qualified healthcare professionals.
1 Singh et al. Egyptian Journal of Neurosurgery (2021) 36:32.
2 Louis DN, Perry A, Wesseling P, Brat DJ, Cree IA, Figarella-Branger D, Hawkins C, Ng HK, Pfister SM, Reifenberger G, Soffietti R, von Deimling A, Ellison DW. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021 Aug 2;23(8):1231-1251. doi: 10.1093/neuonc/noab106. PMID: 34185076; PMCID: PMC8328013.
