Clinical Trials
389
136 active
Approvals
9
Total approvals
Agencies
2
Regulatory bodies
Founded
N/A
Active, not recruiting
134
34.5%
Completed
23
5.9%
Not yet recruiting
2
0.5%
Recruiting
225
57.8%
Suspended
2
0.5%
Withdrawn
3
0.8%
- COUR Pharma secured $50 million in Series B financing led by Lumira Ventures and Roche Venture Fund, with new investment from Sanofi and continued support from Pfizer Ventures, Alpha Wave Ventures, Angelini Ventures, and the T1D Fund. - Proceeds will fund the Phase 2 trial of CNP-103, a nanoparticle-based antigen-specific immune tolerance therapy targeting the underlying autoimmune pathology in type 1 diabetes rather than merely managing blood glucose. - CNP-103 encapsulates four recombinant proteins covering over 95% of known antigens driving T1D, aiming to prevent islet cell destruction and preserve insulin production in patients aged 12–35 diagnosed within six months. - COUR is seeking development partners for two additional pipeline candidates, CNP-104 for primary biliary cholangitis and CNP-106 for myasthenia gravis, as it prioritizes the T1D program.
- India's Patents Act, 1970, through provisions like Section 3(d) and compulsory licensing (Sections 84, 92), systematically prioritizes public health access over pharmaceutical patent monopolies. - The landmark 2012 Bayer v. Natco compulsory license granted Natco Pharma the right to produce generic Nexavar, slashing the monthly cost by 97% from ₹2,80,000 to ₹8,800. - Section 3(d) blocks patent "evergreening" by requiring demonstrated therapeutic efficacy for new forms of known substances, upheld in the 2013 Novartis v. Union of India Supreme Court ruling. - India's pharmaceutical dominance faces a structural vulnerability: approximately 68% of Active Pharmaceutical Ingredients are imported from China, prompting government PLI schemes and bulk drug parks to restore domestic manufacturing.
- Optigo Biotherapeutics has appointed Dr. Andreas Wallnöfer, a pharmaceutical R&D veteran with over 25 years of experience, to its Board of Directors as the company advances its lead anti-VEGF program toward IND-enabling studies. - The company's lead candidate XPK-640 utilizes a proprietary hyaluronic acid-anchoring platform that demonstrated potential to extend aflibercept durability by at least 10-fold in cynomolgus monkey studies, potentially enabling once-yearly dosing. - Wallnöfer previously served as a partner at Jeito Capital where he led early investment in EyeBio, which was acquired by Merck for $3 billion in 2024, and held senior R&D roles at Roche including contributing to Vabysmo development. - The appointment comes as Optigo prepares to enter clinical trials within 12-15 months for neovascular age-related macular degeneration, addressing the significant unmet need of reducing injection burden for patients.
- Mission Therapeutics raised $13.3 million from existing investors to fund Phase Ib clinical trials of MTX325, a first-in-class USP30 inhibitor targeting mitochondrial dysfunction in Parkinson's disease. - The funding follows successful Phase Ia studies demonstrating brain penetration in healthy volunteers and supports regulatory approval from the UK's MHRA for patient trials starting in H1 2026. - MTX325 works by promoting mitophagy to clear dysfunctional mitochondria, with preclinical data published in Nature Communications showing protection against dopaminergic neuron loss and reduced Parkinson's biomarkers. - The Phase Ib trial aims to demonstrate proof-of-mechanism in Parkinson's patients, with results expected in H2 2027, potentially establishing a disease-modifying treatment approach.
- The Delhi High Court dismissed Roche's appeal against Natco Pharma, allowing the launch of a generic version of risdiplam for spinal muscular atrophy treatment. - Natco's generic version will be priced at ₹15,900 per bottle compared to Roche's ₹6.2 lakh, representing a 97% price reduction for this life-saving medication. - The ruling prioritizes public health access over patent protection, potentially enabling more patients to benefit from government support under India's National Policy for Rare Diseases. - Roche expressed disappointment with the decision and emphasized the importance of intellectual property protection for pharmaceutical innovation in India.
- DelveInsight's 2025 pipeline report identifies 7+ companies developing novel Lyme disease therapies, with emerging treatments including BLB 400, FP-100, CT38, TP-05, and VLA15 expected to significantly impact the market. - Valneva and Pfizer reported positive Phase II booster results for their Lyme disease vaccine candidate VLA15 in September 2024, following completion of the primary vaccination series for their Phase III VALOR trial in July 2024. - Tarsus Pharmaceuticals announced encouraging results from their Phase IIa "Tick-Kill" trial of TP-05 (lotilaner) for Lyme disease prevention in February 2024. - The pipeline spans multiple development stages from preclinical to Phase III, with various routes of administration including oral, parenteral, intravenous, subcutaneous, and topical formulations.
- The Delhi High Court denied F. Hoffmann-La Roche's request to access Zydus Lifesciences' manufacturing process for their Pertuzumab biosimilar, ruling that Roche failed to meet mandatory requirements under Section 104A of the Patents Act. - The court established that Section 104A can be invoked at interim stages of patent litigation and prevails over general discovery provisions under the Commercial Courts Act. - The ruling clarifies that "identical product" requirements under Section 104A cannot be diluted for biological drugs, even though absolute replication is scientifically difficult. - The decision impacts ongoing patent disputes in India's biosimilar market, particularly for cancer treatments where regulatory reference to branded biologics does not automatically imply process infringement.
- SpliceBio secured $135 million in Series B funding co-led by EQT Life Sciences and Sanofi Ventures to advance SB-007, the first dual AAV gene therapy cleared by FDA for Stargardt disease treatment. - The company's proprietary Protein Splicing platform addresses a fundamental limitation of AAV vectors by enabling delivery of large genes that exceed the 4.7 kilobase packaging capacity through engineered inteins. - SB-007 has received Orphan Drug Designation from both FDA and European Commission, with the first patient dosed in the Phase 1/2 ASTRA study in March 2025. - The platform technology has transformative potential across ophthalmology and neurology by unlocking treatment possibilities for genetic disorders previously considered untreatable due to large gene size limitations.
- SpliceBio secured $135 million in Series B funding co-led by EQT Life Sciences and Sanofi Ventures to advance its lead gene therapy candidate SB-007 for Stargardt disease. - The company's innovative Protein Splicing platform overcomes the challenge of delivering large genes by splitting them into smaller pieces that reassemble into full-length proteins. - SB-007 targets Stargardt disease, the most common inherited macular degeneration affecting 1 in 8,000-10,000 people with no approved treatments currently available. - The technology has potential to address over 1,200 known mutations causing Stargardt disease and could unlock treatments for other genetic disorders involving large genes.
- The Delhi High Court has ordered Natco Pharma to maintain status quo on launching its generic version of Risdiplam, a treatment for spinal muscular atrophy, until April 2 amid Roche's patent infringement appeal. - Roche's branded Evrysdi (Risdiplam) costs approximately Rs 6 lakh per bottle in India, while Natco's proposed generic version would be priced 80-90% lower, raising significant affordability and access concerns for patients. - The case highlights the tension between patent protection and public health interests, with SMA patients intervening to emphasize their right to affordable treatment for this rare genetic disease.
