Tuberculosis Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, IND, ROA, MOA, NDA Approval and Companies involved by DelveInsight

(Albany, USA) DelveInsight's "Tuberculosis Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the tuberculosis market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging tuberculosis drugs, the tuberculosis pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

The tuberculosis market is gaining renewed momentum with the development of advanced vaccines and novel drug regimens by key players such as Biofabri, Serum Institute of India, GlaxoSmithKline, BioVersys, and Sequella. As resistance to first-line treatments increases, the pipeline is shifting toward shorter, more potent therapies and next-generation TB vaccines targeting both latent and active infections. With global health initiatives pushing for better diagnostics and more effective tools, the market is poised for a breakthrough in TB prevention and cure strategies.

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Key Takeaways from the Tuberculosis Pipeline Report
• DelveInsight's tuberculosis pipeline analysis depicts a robust space with 30+ active players working to develop 35+ pipeline drugs for tuberculosis treatment.
• The leading Tuberculosis companies include Biofabri, Serum Institute of India Pvt. Ltd., Shanghai Jiatan Pharmatech, Sequella, Inc., LegoChem Biosciences, GlaxoSmithKline, BioVersys, BioNTech, and others are evaluating their lead assets to improve the Tuberculosis treatment landscape.
• Key Tuberculosis pipeline therapies in various stages of development include MTBVAC, VPM1002, WX-081, Sutezolid, LCB01-0371, GV118819, BVL-GSK098, BNT-164, and others.
• In April 2025, Revvity, Inc. announced FDA approval of the Auto-Pure 2400 liquid handling platform for use with the T-SPOTTM.TB test. Originally launched outside the U.S. in 2024, this high-throughput solution enhances lab efficiency and ensures accurate latent TB detection-supporting faster diagnosis and timely treatment worldwide.
• In January 2025, IntelliGenome announced that the FDA granted Breakthrough Device Designation to its CRISPR-Tuberculosis Blood Test. This test is the first qualitative real-time PCR assay combining CRISPR technology to detect Mycobacterium tuberculosis (Mtb) cell-free DNA in human serum and EDTA plasma.

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Tuberculosis Overview
Tuberculosis (TB), caused by Mycobacterium tuberculosis (Mtb), is a deadly infectious disease with a long history, dating back to ancient times. Despite the availability of the Bacille Calmette-Guérin (BCG) vaccine and effective short-course chemotherapy (DOTS), TB remains a global health challenge, exacerbated by drug-resistant strains and its synergy with HIV. Identified by Robert Koch in 1882 and with its complete genome mapped in 1998, TB continues to pose a threat, with factors like poverty, overcrowding, and poor healthcare infrastructure hindering prevention efforts. Symptoms, including persistent cough, chest pain, fever, and weight loss, vary by age and disease form. TB is diagnosed through tests like chest X-rays, sputum culture, and molecular assays. Treatment involves a six-month regimen of multiple antibiotics, though drug-resistant TB requires extended therapy. Timely diagnosis, adherence to treatment, and public health measures like vaccination, contact tracing, and improved living conditions are essential in controlling TB and reducing its transmission.

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Tuberculosis Treatment Analysis: Drug Profile
MTBVAC: Biofabri
MTBVAC is a novel tuberculosis vaccine developed by the Mycobacteria Genetics Group at the University of Zaragoza. It is formulated from a human-isolated strain and is designed to activate the immune system to recognize the infectious agent, offering long-term protection against tuberculosis. Preclinical studies in various animal models have shown that MTBVAC is safe and provides enhanced protection compared to the BCG vaccine. The vaccine is currently in Phase III development for the treatment of tuberculosis.

LCB01-037: LigaChem Biosciences, Inc.
LCB01-037 (delpazolid) is a new oxazolidinone antibacterial agent developed by LigaChem Biosciences to treat multi-drug resistant gram-positive infections. This novel molecule works by inhibiting protein synthesis in bacteria, binding to the 23S ribosomal RNA to prevent protein translation. Early studies in tuberculosis patients showed that LCB01-037 reduced bacterial load at rates similar to standard anti-TB therapy. The drug has completed Phase I trials, demonstrating good safety and tolerability. It is currently in Phase II clinical trials for tuberculosis treatment.

Key Tuberculosis Therapies and Companies
• MTBVAC: Biofabri
• LCB01-037: LigaChem Biosciences, Inc.
• BNT-164: BioNTech

Learn more about the novel and emerging Tuberculosis pipeline therapies @ https://www.delveinsight.com/sample-request/tuberculosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Tuberculosis Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intranasal
• Intrathecal
• Intravenous
• Oral
• Oral/Intravenous
• Parenteral
• Subcutaneous
• Subcutaneous/Intramuscular
• Transdermal

By Molecule Type
• Gene therapy
• Hormones
• Neuropeptides
• Oligonucleotides
• Small Molecule
• Triglyceride

Scope of the Tuberculosis Pipeline Report
• Coverage: Global
• Key Tuberculosis Companies: Biofabri, Serum Institute of India Pvt. Ltd., Shanghai Jiatan Pharmatech, Sequella, Inc., LegoChem Biosciences, GlaxoSmithKline, BioVersys, BioNTech, and others.
• Key Tuberculosis Pipeline Therapies: MTBVAC, VPM1002, WX-081, Sutezolid, LCB01-0371, GV118819, BVL-GSK098, BNT-164, and others.

Dive deep into rich insights for drugs used for Tuberculosis treatment; visit @ https://www.delveinsight.com/sample-request/tuberculosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Contents
1. Introduction
2. Executive Summary
3. Tuberculosis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Tuberculosis Pipeline Therapeutics
6. Tuberculosis Pipeline: Late-Stage Products (Phase III)
7. Tuberculosis Pipeline: Mid-Stage Products (Phase II)
8. Tuberculosis Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679
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About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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