Indian Pharmaceutical Industry Monitor

Pharmaceutical Industry News

Clinical Trials & Research

Clinical trials ecosystem is entering a rapid growth phase, supported by regulatory reform, expanding infrastructure, and rising global interest.

Latest major ongoing and recently registered clinical trials across India and international centers:

Indian Clinical Trials (CDSCO / CTRI Registered)

  1. Phase III Multi-Centric Trial on Iron Deficiency Anaemia (ICMR-CCRAS)
    • Focus: Efficacy and safety of traditional Ayurvedic formulations (Punarnavadi Mandura and Drakshavaleha) compared to standard oral Iron Folic Acid (IFA) supplementation.
    • Participants: ~4,000 non-pregnant women across 12 Indian medical centers.
    • Status: Phase III evaluation demonstrated therapeutic equivalency to standard IFA with lower gastrointestinal side effects.
  2. Phase II/III Trial of Indigenous Chimeric Antigen Receptor (CAR-T) Therapy
    • Focus: Nationally developed ACT-101 CAR-T cell therapy targeting CD19-positive relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL).
    • Sponsor/Centers: IIT Bombay, Tata Memorial Centre, and ImmunoACT across multi-tier Indian cancer institutes.
    • Status: Ongoing Phase II/III expanding to Tier-2 medical centers for cost-effective cell therapy access.
  3. Phase III Trial of Oral Direct-Acting Antiviral FDC for Dengue Fever
    • Focus: Evaluating a novel oral small-molecule combination therapy aimed at reducing viral load and preventing severe plasma leakage in acute dengue infection.
    • Sponsor: Pan-India multi-site clinical network led by Indian pharmaceutical majors and ICMR.
    • Status: Active Phase III multi-center enrollment during monsoon endemic surges.
  4. Phase II Trial of Oral GLP-1 Receptor Agonist for Metabolic Dysfunction-Associated Steatohepatitis (MASH/NASH)
    • Focus: Assessing liver fat reduction, fibrosis improvement, and glycemic control in Indian patients with non-alcoholic fatty liver disease.
    • Sponsor: Zydus Lifesciences / Sun Pharma.
    • Status: Active Phase II trial across major gastroenterology and endocrine units in India.
  5. Phase III Multi-Site Study on Fixed-Dose Triple Combination for Uncontrolled Hypertension
    • Focus: Single-pill combination of Telmisartan, Amlodipine, and Chlorthalidone to evaluate 24-hour ambulatory blood pressure control in South Asian populations.
    • Sponsor: Multi-centric trial involving Tier-1 and Tier-2 hospital networks (StriderDCT / Indian Clinical Research Network).
    • Status: Phase III recruitment active.
  6. Phase I First-In-Human (FIH) Trial of Novel Biological Anti-TNF Alpha Biosimilar
    • Focus: Safety, pharmacokinetics, and immunogenicity of a next-generation biosimilar monoclonal antibody for severe Rheumatoid Arthritis and Ankylosing Spondylitis.
    • Sponsor: Biocon Biologics / Dr. Reddy’s Laboratories under ICMR Phase 1 trial guidelines.
    • Status: Active Phase I dosing at dedicated early-phase clinical trial units in India.
  7. Phase III Pragmatic Trial on Short-Course Oral Regimen for Drug-Resistant Tuberculosis (DR-TB)
    • Focus: Evaluating an all-oral, 6-month, Bedaquiline-Pretomanid-Linezolid-Moxifloxacin (BPaLM) regimen under the National TB Elimination Program.
    • Sponsor: ICMR-National Institute for Research in Tuberculosis (NIRT).
    • Status: Phase III multi-center implementation trial in advanced monitoring stages.

International Clinical Trials (US FDA / EMA Registered)

1. VIKTORIA-1 Trial (Phase III) – Gedatolisib Combination in Advanced Breast Cancer

  • Focus: Gedatolisib (pan-PI3K/mTOR inhibitor) combined with fulvestrant ± palbociclib in HR-positive, HER2-negative advanced or metastatic breast cancer.
  • Sponsor: Celcuity Inc. (Global sites: US, Europe, Asia).
  • Status: Phase III readout met primary progression-free survival (PFS) endpoints; under Priority FDA/EMA review.

2. SUMMIT Phase III Trial – Tirzepatide in Heart Failure with Preserved Ejection Fraction (HFpEF)

  • Focus: Evaluating the dual GIP/GLP-1 receptor agonist tirzepatide in reducing cardiovascular death and heart failure events in obese patients with HFpEF.
  • Sponsor: Eli Lilly and Company (International multi-center trial).
  • Status: Active Phase III pivotal study.

3. TROPION-Lung01 Phase III Trial – Datopotamab Deruxtecan (Dato-DXd)

  • Focus: TROP2-directed antibody-drug conjugate (ADC) vs. docetaxel in patients with previously treated advanced or metastatic Non-Small Cell Lung Cancer (NSCLC).
  • Sponsor: AstraZeneca and Daiichi Sankyo.
  • Status: Phase III global registrational trial under global regulatory evaluation.

4. HERCULES Phase III Trial – Tolebrutinib in Non-Relapsing Secondary Progressive Multiple Sclerosis (nrSPMS)

  • Focus: Oral Bruton’s Tyrosine Kinase (BTK) inhibitor to delay disability progression in chronic neurodegenerative MS.
  • Sponsor: Sanofi (Global multi-center).
  • Status: Pivotal Phase III trial assessing long-term neurological outcome endpoints.

5. Phase III ZENITH Trial – Zidesamtinib in Advanced ROS1-Positive Lung Cancer

  • Focus: Next-generation brain-penetrant ROS1 tyrosine kinase inhibitor designed to bypass solvent-front resistance mutations in metastatic NSCLC.
  • Sponsor: Nuvalent Inc. (US, EU, East Asia).
  • Status: Phase III global study following initial priority review designations.

6. Phase II/III Trial of Oral GLP-1 Small Molecule Orforglipron

  • Focus: Non-peptide, once-daily oral GLP-1 receptor agonist for long-term weight management and cardiovascular risk reduction without cold-chain storage requirements.
  • Sponsor: Eli Lilly / International Clinical Research Sites.
  • Status: Global Phase III clinical trials actively enrolling across continents.

7. Phase III KOMET Trial – KRAZATI (Adagrasib) in KRAS G12C-Mutant Colorectal Cancer

  • Focus: Adagrasib combined with cetuximab versus standard chemotherapy in previously treated KRAS G12C-mutated metastatic colorectal cancer.
  • Sponsor: Bristol Myers Squibb / Mirati Therapeutics (Global trial sites).
  • Status: Phase III registration trial.

8. Phase I/II First-in-Human Trial of In Vivo CRISPR/Cas9 Gene Editing for Hereditary Angioedema

Status: Active Phase II/III transition following Phase I safety readout.

Focus: Intravenous single-dose gene editing therapy (NTLA-2002) targeting the KLKB1 gene to prevent severe swelling attacks.

Sponsor: Intellia Therapeutics (Global early-phase research sites).