Indian pharmaceutical company Shilpa Medicare Limited has achieved a milestone in oncology supportive therapy. The Phase 3 study for OERIS™, an innovative depot injection containing the active ingredient Ondansetron, met all primary and secondary endpoints. This once-weekly formulation offers extended coverage against acute and delayed nausea and vomiting in chemotherapy patients, surpassing conventional injections in efficacy, tolerability, and patient comfort. The success underscores the growing role of Indian firms in developing differentiated medicines and could sustainably transform the market for supportive oncological therapies.
Ondansetron, a serotonin 5-HT3 receptor antagonist, has been a standard treatment for chemotherapy-induced nausea and vomiting (CINV) since the 1990s. The classic application involves multiple daily injections or tablets, which is burdensome for patients with severe side effects and weakened immune systems. CINV affects up to 80 percent of those affected and often leads to treatment discontinuation, significantly reducing quality of life. At a time when global cancer incidence is rising – with over 1.4 million new cases diagnosed annually in India alone – the need for patient-friendly solutions is growing. The market for CINV therapeutics currently stands at around US$2.5 billion and is projected to grow to over $9 billion by 2033, driven by advances in chemotherapy and higher survival rates. Shilpa Medicare is positioning itself as an innovator here by transforming established active ingredients into advanced dosage forms.
The SMLINJ011 study, the company's fourth complex clinical development, was designed as a multicenter, randomized, double-blind, non-inferiority trial. OERIS™ was compared to standard ondansetron therapy in 240 patients at Indian oncology centers, in individuals with moderately to highly emetogenic chemotherapy regimens. The primary endpoint – complete response, defined as no vomiting events within 120 hours after therapy initiation – was achieved by 89 percent in the OERIS group, compared to 82 percent in the control group. Secondary objectives such as delayed phase control and tolerability also showed advantages: No serious adverse events occurred, and overall safety was comparable or better. These results suggest a reduction in treatment burden, as a single injection provides up to five days of protection without oral follow-up or multi-day dosing.
Shilpa Medicare, founded in 1989 in Raichur in southern India, has evolved from a small API manufacturer into a global player in oncology and specialty pharmaceuticals. The company produces active pharmaceutical ingredients, finished dosage forms, and biologics, exporting to over 80 countries, including the USA and Europe. With revenue growth of over 20 percent in fiscal year 2024/25 and a stock listing on BSE and NSE (share price around 500 rupees), it benefits from the "Make in India" initiative and stricter FDA standards. OERIS™ fits into a strategy focused on differentiated generics: previous successes include depot formulations of leuprolide for prostate cancer and irinotecan liposomes for colorectal carcinomas. The focus on supportive therapy addresses a growing segment where patient compliance and quality of life are key criteria. Experts see such innovations as a way for emerging markets like India – with its booming generics industry – to challenge established corporations like Merck or Helsinn.
The background of the development reflects global challenges. Chemotherapy remains a cornerstone of cancer treatment, but side effects like CINV affect millions of patients annually. In emerging markets, where resources are scarce, the need for multiple doses increases costs and complication risks. OERIS™ addresses this through a depot technology that releases the active ingredient in a controlled manner – a method based on microspheres or polymer matrices, which is established in oncology. The study, conducted in cooperation with leading Indian clinics, meets international standards and paves the way for approvals. Shilpa now plans to file with the Drugs Controller General of India (DCGI) and pursue a 505(b)(2) shortcut with the US FDA, building on existing data from the reference product. This could accelerate market entry in the USA, where the CINV market alone is worth 1.5 billion US dollars.
The implications extend beyond Shilpa. For patients, OERIS™ means less burden: no need for outpatient administration, increased adherence, and minimized therapy discontinuation. Clinicians benefit from simplified protocols, which is welcome in overburdened oncology departments. Economically, Shilpa's success strengthens its portfolio: the company recently raised 500 million rupees through a capital increase to finance research projects. Analysts predict a stock increase of 10-15 percent, as OERIS™ has the potential to capture 5-10 percent of the CINV market, especially in Asia and Africa. At the same time, the milestone underscores the shift in the pharmaceutical industry: while Big Pharma focuses on novelties, generics specialists are gaining ground through smart reformulations. In India, the "Pharmacy of the World," where over 20 percent of global generics are produced, this promotes exports and creates high-tech pharmaceutical jobs.
Looking ahead, OERIS™ could be a catalyst for further innovation. Shilpa is investing in biologics and personalized medicine, such as CAR-T cell therapies, and plans expansions in Europe. The success also addresses regulatory hurdles: the FDA has recently scrutinized Indian facilities more closely, but Shilpa's GMP certification protects against setbacks. In the context of rising cancer rates – the WHO estimates 35 million cases by 2050 – supportive therapies are becoming essential. OERIS™ demonstrates how technology can alleviate suffering: one injection instead of dozens of pills means freedom for patients already battling the disease.
This breakthrough marks Shilpa as a pioneer in patient-centric oncology. In an industry that pumps billions into supportive care annually, OERIS™ offers not just efficacy, but real added value. Upcoming approvals could pave the way for global partnerships and further strengthen India's pharmaceutical sector. For cancer patients worldwide, simpler therapy is within tangible reach – progress that combines innovation and humanity.
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Sources:
- https://www.prnewswire.com/news-releases/shilpa-medicare-announces-positive-phase-3-results-for-oeris–a-novel-once-weekly-ondansetron-extended-release-injection-for-chemotherapy-induced-nausea-and-vomiting-cinv-302610669.html
- https://www.news9live.com/health/health-news/shilpa-medicare-oeris-phase-3-trial-results-2903240
- https://www.devdiscourse.com/article/health/3692803-shilpa-medicares-oerist-a-breakthrough-in-cinv-management
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