相关临床试验
1027
626 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1911
进行中（未招募）
64
6.2%
已完成
185
18.0%
尚未招募
562
54.7%
招募中
204
19.9%
暂停
2
0.2%
Unknown
6
0.6%
暂无批准数据
- Takeda Biopharmaceuticals India and Dr Reddy's Laboratories have entered a distribution agreement covering QDENGA, India's first approved dengue vaccine, in the country's private market. - Dr Reddy's will exclusively promote and distribute QDENGA for paediatric and adult vaccination, with availability anticipated in the first half of 2027 pending local authority processes. - The deal follows CDSCO marketing authorisation in July 2026 for individuals aged 4 to 60 years, and Takeda retains public-market rights plus medical and brand oversight. - Dengue cases in India have risen 11-fold over two decades, and a nationwide ICMR surveillance study found all four serotypes co-circulating, with 1 in 14 patients infected with multiple serotypes.
- The Union Health Ministry issued a 16 September 2026 advisory barring stem cell therapy as standard care outside indications approved by the Ministry. - The advisory implements a January 2026 Supreme Court ruling that unapproved stem cell therapy cannot be offered as routine or commercial treatment for autism. - Stem cell use in autism must remain confined to duly approved clinical trials under the National Guidelines for Stem Cell Research, 2017. - Non-compliance may trigger professional misconduct charges and action under the Clinical Establishments Act, including registration cancellation and penalties.
- Scientist and innovation strategist Dr. Ramji Pallela called on Osmania University life sciences students to transform academic research into market-ready products, technologies, and startups. - Pallela highlighted funding opportunities through Indian agencies including BIRAC, DBT, DST, CSIR, ICMR, and ANRF, alongside internships, fellowships, and seed funding programs. - Students were encouraged to pursue intellectual property rights, technology transfer, and interdisciplinary collaboration to move scientific discoveries from laboratories to wider use. - The session emphasized early engagement in innovation challenges and entrepreneurship programs rather than waiting until the end of academic careers.
- Zydus Lifesciences has received regulatory approval to conduct a Phase III clinical trial of oral desidustat in 164 patients with sickle cell disease, in collaboration with the Indian Council of Medical Research (ICMR). - The 203-day study follows a successful Phase II trial in which the 150 mg dose demonstrated promising hemoglobin improvement with minimal adverse events. - Desidustat, a hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI), stimulates endogenous erythropoietin production and iron utilization, offering a novel oral mechanism for treating anemia in sickle cell disease. - The drug is already approved in India and China for renal anemia and holds US FDA Orphan Drug Designation for sickle cell disease, positioning it for potential global development.
- The Indian Council of Medical Research (ICMR) has licensed three indigenous biomedical technologies to Emcure Pharmaceuticals and Biological E under its Medical Innovations Patent Mitra initiative. - SHetA2, a first-in-class anti-HPV therapeutic candidate for Cervical Intraepithelial Neoplasia (CIN), was licensed to Emcure Pharmaceuticals for further development and commercialization. - Two next-generation vaccine technologies targeting Salmonella typhi, Salmonella paratyphi, and Shigella infections were licensed to Biological E Ltd., developed at ICMR-NIRBI, Kolkata. - The technology transfers aim to accelerate publicly funded research into affordable healthcare solutions and strengthen India's biomedical innovation ecosystem.
- The Indian Council of Medical Research found that six-month all-oral BPaL and BPaLM regimens for multidrug-resistant tuberculosis are more cost-effective than traditional 9-20 month treatments. - The BPaL regimen saves Rs 379 per patient for each quality-adjusted life year gained compared to standard care, while BPaLM adds only Rs 37 per additional QALY. - These shorter regimens eliminate painful injections, reduce treatment duration from up to 20 months to six months, and improve patient adherence rates. - The economic evidence supports programmatic adoption under India's National TB Elimination Programme to accelerate progress toward tuberculosis elimination.
- The Indian Council of Medical Research has successfully developed a two-dose adjuvanted inactivated vaccine for Kyasanur Forest Disease and initiated Phase I human clinical trials following regulatory approval. - The indigenous vaccine, developed in collaboration with Indian Immunologicals Limited, targets a significant regional infectious disease affecting Western Ghats states including Karnataka, Tamil Nadu, Kerala, Goa, and Maharashtra. - Animal challenge and toxicity studies have been completed, with GLP-grade vaccine material manufactured and regulatory approval obtained from the Central Drugs Standard Control Organization. - If Phase I trials demonstrate safety and immunogenicity, the vaccine will advance to further clinical development phases with potential for regulatory approval.
- India's Central Drugs Standard Control Organization (CDSCO) is creating a 1,500-member scientific cadre to address resource constraints and speed up drug approval timelines. - Approximately 40% of the workforce will be hired on contract basis, with potential to engage global industry experts and specialists across fields like microbiology, biotechnology, and biostatistics. - The regulator is also planning to outsource GMP and GCP audits to Quality Council of India-certified agencies to bridge capacity gaps in the regulatory ecosystem. - These initiatives aim to align India's regulatory standards with global benchmarks and potentially achieve approval timelines better than the US FDA.
- The Indian Council of Medical Research (ICMR) has issued an Expression of Interest seeking collaboration with Indian industry partners to manufacture indigenously developed monoclonal antibodies against Nipah virus following successful animal trials. - With no licensed vaccines or antivirals available globally, monoclonal antibodies represent the most promising therapeutic option for Nipah virus, which has an extremely high fatality rate and poses significant zoonotic threats to India since 2001. - The m102.4 monoclonal antibody, targeting the G glycoprotein of Nipah virus, has demonstrated strong protection in animal models and safety in Phase 1 clinical trials, with potential for post-exposure prophylaxis and early therapeutic intervention. - ICMR-National Institute of Virology in Pune has advanced experimental work underway and will provide technical support through its BSL-3 and BSL-4 facilities to ensure rapid deployment during future outbreaks.
- The World Health Organization launched the Global Clinical Trials Forum (GCTF), a multi-stakeholder network designed to strengthen clinical trial environments and infrastructure globally. - Indian institutions including ICMR, St. John's Medical College Bengaluru, and Christian Medical College Vellore joined as launch members alongside The George Institute. - Industry experts predict the initiative will enhance India's clinical research capabilities through improved trial standards, increased global collaboration, and alignment with WHO best practices. - The forum aims to implement WHO's Guidance for Best Practices for Clinical Trials and address barriers across current clinical trial ecosystems through nine priority action areas.
