# Zydus Lifesciences 已獲印度藥品監管總局（DCGI）批准啟動兩項 Zintrodiazine 第三期臨床試驗。 *biotech · news · 2026-04-27 · scanx.trade* ## Key points - Zydus Lifesciences 獲得 DCGI 批准啟動兩項 Zintrodiazine 第三期臨床試驗。 - Zintrodiazine 針對包括抗藥性瘧疾株在內的 P. falciparum 和 P. vivax。 - 每項試驗均以 PCR 調整的 ACPR 作為評估 Zintrodiazine 主要療效的終點。 - 「Saksham Niveshak」活動直接針對截至 2026 年 7 月 9 日未支付或未領取股息的股東。 - Zydus 以英語和古吉拉特語發布活動資訊，以最大化股東覆蓋率和合規性。 Zydus Lifesciences has received approval from the Drug Controller General of India (DCGI) to initiate two Phase III clinical trials for Zintrodiazine, a novel anti-malarial candidate active against all current clinical strains of Plasmodium falciparum and Plasmodium vivax, including drug-resistant strains. The announcement was made through a press release dated April 25, 2026. Clinical Trial Details The company will conduct two multi-centre, randomised, assessor-blind, active-comparator studies to evaluate the efficacy, safety and tolerability of orally administered Zintrodiazine. The first Phase III trial will involve 651 patients with uncomplicated malaria due to P. falciparum, while the second trial will enroll 390 patients with uncomplicated P. vivax malaria. Both trials will use PCR-adjusted adequate clinical and parasitological response (ACPR) as the primary efficacy endpoint. Trial Parameter P. falciparum Study P. vivax Study Patient Count 651 390 Study Type Multi-centre, randomised, assessor-blind, active-comparator Multi-centre, randomised, assessor-blind, active-comparator Primary Endpoint PCR-adjusted ACPR PCR-adjusted ACPR Secondary endpoints in both trials will include the incidence of recrudescence, new infections, parasite clearance time and fever clearance time. Strategic Context and Collaboration Last year, over 1,80,000 people were diagnosed with malaria in India. In 2016, Medicines for Malaria Venture (MMV) and Zydus announced a collaboration to develop a Zintrodiazine-containing drug combination as an effective alternative to current artemisinin-based combination therapies (ACTs), which face increasing resistance threats. The WHO's World Malaria Report 2025 notes that partial resistance to artemisinin derivatives has been confirmed or suspected in at least 8 countries in Africa. Company Perspective Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited, stated that the approval marks a critical milestone in the fight against malaria. He emphasized the company's commitment to developing effective treatments to address the challenge of increasing resistance to current therapies. Zydus Lifesciences employs over 29,000 people worldwide, including 1,500 scientists engaged in research and development. Zydus life science has officially published its notice for the second 100-day investor awareness campaign titled 'Saksham Niveshak' in Financial Express on April 22, 2026. The pharmaceutical company simultaneously communicated this publication to both major stock exchanges, demonstrating compliance with regulatory disclosure requirements. Official Publication and Exchange Communication The company published the campaign notice in both English and Gujarati editions of Financial Express on April 22, 2026. Zydus Lifesciences promptly informed the listing departments of BSE Limited and National Stock Exchange of India Limited about this newspaper publication through official correspondence. Exchange Details: Information BSE Code: 532321 NSE Code: Zyduslife Publication Date: April 22, 2026 Languages: English and Gujarati Newspaper: Financial Express Campaign Overview and Timeline The 'Saksham Niveshak' campaign, launched following directives from the Investor Education and Protection Fund Authority (IEPFA), commenced on April 1, 2026, and will continue until July 9, 2026. This initiative specifically targets shareholders whose dividends have remained unpaid or unclaimed, forming part of IEPFA's broader drive for investor education and facilitation. Campaign Parameter: Details Campaign Name: Saksham Niveshak Duration: April 1, 2026 to July 9, 2026 Total Days: 100 days Target Audience: Shareholders with unpaid/unclaimed dividends Authority: IEPFA directive Shareholder Action Requirements The campaign addresses shareholders who need to update their Know Your Customer (KYC) and nomination details or have issues related to unpaid dividends and shares. Shareholders requiring assistance can contact the company's Registrar and Share Transfer Agent, MUFG Intime India Private Limited (formerly Link Intime India Private Limited), located at 5th Floor, 506 to 508, Amarnath Business Centre – I (ABC-I), Besides Gala Business Centre, Off C. G. Road, Ellisbridge, Ahmedabad-380006. Contact Information and Accessibility For direct communication, shareholders can reach the company's Nodal Officer at companysecretary@zyduslife.com or contact the Registrar at telephone numbers 079-26465179/86/87 and email ahmedabad@in.mpms.mufg.com . The notice, signed by Dhaval N. Soni, Company Secretary and Compliance Officer (Membership No. FCS7063), is available on the company website at www.zyduslife.com and stock exchange websites at www.nseindia.com and www.bseindia.com . The bilingual publication approach ensures maximum reach among shareholders across different linguistic backgrounds, emphasizing the company's commitment to inclusive communication and regulatory compliance in preventing shares from being transferred to the IEPF. We’re building Scanx - to help you express your trading & investing idea, to help you analyse the markets better. Stock Markets are the true indicator of the growth of any country's economy. We are bullish on India, we are bullish on India's prospects to be one of largest economies of the world. We believe that Stock Markets provide an unique opportunity for all Indians to participate in the growth story of India. We are enabling the same for Indians. As financial services are becoming more accessible, there is now a large set of Indians today who are financially aware and literate. They value time and seek high quality products & services. Most screening, trading, investing platforms available today are more or less similar to each other, and they have not evolved with time. While both traders & investors have gotten smart about how they make money and build wealth, as users they have continued to use the same products, features, and platforms that were available for years with little or no innovation. We plan to change that - a technology-led platform built for super traders and long term investors. **Companies:** Zydus Lifesciences **Countries:** India [Read the full story on scanx.trade](https://scanx.trade/stock-market-news/companies/zydus-lifesciences-receives-dcgi-approval-to-begin-phase-iii-trials-for-anti-malaria-drug-zintrodiazine/38647737) --- Canonical: https://newsio.io/zh-TW/n/7adb1f3f-c2f4-4a94-b016-91748123ea1a/zydus-lifesciences-dcgi-zintrodiazine-651-p Summarized by Newsio from scanx.trade. https://newsio.io/how-it-works