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NTM Infections Pipeline

Key Nontuberculous Mycobacterial Infections Companies include Insmed Incorporated, Savara Inc, Paratek Pharmaceuticals Inc, LigaChem Biosciences, Spero Therapeutics, Mannkind Corporation, Pfizer, Agouron Pharmaceuticals, Pharmacia, Janssen Pharmaceutical K.K., and others.

According to DelveInsight’s evaluation, the global Nontuberculous Mycobacterial (NTM) Infections pipeline includes 10+ leading companies actively engaged in advancing more than 10 therapeutic candidates. The analysis highlights ongoing progress in clinical trials, therapeutic approaches, mechanisms of action, routes of administration, and developmental milestones.

DelveInsight’s report, “Nontuberculous Mycobacterial Infections Pipeline Insight, 2025”, provides a detailed overview of the current clinical landscape and future opportunities within the NTM Infections market.

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What Are the Key Highlights from the NTM Infections Pipeline Report?

• Several Nontuberculous Mycobacterial (NTM) Infection companies worldwide are consistently working to develop innovative therapies for NTM infections, with notable advancements in recent years.
• Key Nontuberculous Mycobacterial Infections Companies include Insmed Incorporated, Savara Inc, Paratek Pharmaceuticals Inc, LigaChem Biosciences, Spero Therapeutics, Mannkind Corporation, Pfizer, Agouron Pharmaceuticals, Pharmacia, Janssen Pharmaceutical K.K., and others.
• Prominent Nontuberculous Mycobacterial (NTM) Infections emerging therapies include ALIS, Antimycobacterial regimen, Omadacycline Oral Tablet, Delpazolid, SPR720, Clofazimine Inhalation Suspension, Ethambutol hydrochloride, Nelfinavir mesylate, Bedaquiline, and more – expected to significantly influence the NTM Infections market.
• In April 2025, MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for MNKD-101 (Clofazimine Inhalation Suspension), enabling the initiation of a Phase 3 study for the treatment of nontuberculous mycobacterial (NTM) lung disease.
• In April 2025, Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”), a commercial-stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,274,830. The issued patent gives the Company protection for its method of delivering gaseous nitric oxide (gNO) to a patient that has a condition associated with non-tuberculous mycobacteria (NTM) lung infection.
• In January 2025, Shanghai MicuRx Pharmaceutical Co., Ltd. (“MicuRx”，688373.SH) announced that MRX-5, its self-developed anti-infection drug, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of non-tuberculous mycobacteria (NTM) infections. This designation marks a significant milestone for MicuRx in the field of NTM infection treatment.
• November 2024: Paratek Pharmaceuticals announced positive topline Phase IIb data for Nuzyra (omadacycline) in NTM pulmonary disease, showing ≥50% symptom improvement from baseline.
• October 2024: Spero Therapeutics reported interim Phase 2a results of SPR720, demonstrating antimicrobial activity but also raising safety concerns at higher doses, which led to a temporary halt in its development strategy.

What Are Nontuberculous Mycobacterial (NTM) Infections?

NTM Infections are caused by diverse environmental mycobacteria – excluding Mycobacterium tuberculosis and Mycobacterium leprae – commonly found in soil, dust, and water. These infections predominantly affect the lungs but may also involve skin, lymph nodes, and other organs, especially in immunocompromised patients.

While not contagious, NTM Infections are chronic and difficult to treat. Symptoms such as persistent cough, weight loss, fatigue, and breathlessness often mimic tuberculosis or other lung conditions. Diagnosis typically involves sputum cultures, imaging, and molecular testing.

Major causative species include Mycobacterium avium complex (MAC) and Mycobacterium abscessus. Treatment generally requires prolonged multi-drug antibiotic regimens extending over a year, with resistance posing major challenges. Rising prevalence is linked to better diagnostics, increased awareness, and aging populations.

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Which Nontuberculous Mycobacterial Infections Emerging Therapies Are Under Development?

• ALIS – Insmed Incorporated
• Antimycobacterial regimen – Savara Inc
• Omadacycline Oral Tablet – Paratek Pharmaceuticals Inc
• Delpazolid – LigaChem Biosciences, Inc.
• SPR720 – Spero Therapeutics
• Clofazimine Inhalation Suspension – Mannkind Corporation
• Ethambutol hydrochloride – Pfizer, Pharmacia
• Nelfinavir mesylate – Agouron Pharmaceuticals
• Bedaquiline – Janssen Pharmaceutical K.K.

How Are Nontuberculous Mycobacterial Infection Therapies Being Administered?

Pipeline therapies are being evaluated across multiple routes of administration (ROA):

• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

What Types of Molecules Are in Development?

Therapies fall under various molecular categories, including:

• Small molecules
• Monoclonal antibodies
• Peptides
• Polymers
• Gene therapies

Further Nontuberculous Mycobacterial Infections product details are provided in the report. Download the Nontuberculous Mycobacterial Infections pipeline report to learn more about the emerging Nontuberculous Mycobacterial Infections therapies at:Nontuberculous Mycobacterial Infections Drugs and Therapies

Nontuberculous Mycobacterial Infections Therapeutic Assessment

How Is the Nontuberculous Mycobacterial Infections Pipeline Being Assessed?

• By product type and stage of development (early, mid, late phase)
• By route of administration
• By molecular type
• Active vs. inactive (discontinued/dormant) projects
• Collaborative and licensing activities

What Factors Are Driving the NTM Infections Market?

• Rising incidence of NTM infections
• Advancements in diagnostic methods
• Increasing awareness and screening initiatives
• Growing elderly and immunocompromised populations
• Expanding pipeline and ongoing R&D investments

What Barriers Are Hindering Market Growth?

• Limited available treatment options
• Long and costly treatment regimens
• Side effects from prolonged antibiotic use
• Resistance to current therapies
• Low commercial interest and regulatory hurdles

Download Sample PDF Report to know more about Nontuberculous Mycobacterial Infections drugs and therapies –Nontuberculous Mycobacterial Infections Clinical Trial and FDA Approvals

What Is the Scope of the Nontuberculous Mycobacterial Infections Pipeline Report?

• Coverage: Global
• Key Nontuberculous Mycobacterial Infections Companies: Insmed Incorporated, Savara Inc, Paratek Pharmaceuticals Inc, LigaChem Biosciences, Inc., Spero Therapeutics, Mannkind Corporation, Pfizer, Agouron Pharmaceuticals, Pharmacia, Janssen Pharmaceutical K.K., and others
• Key Nontuberculous Mycobacterial Infections Therapies: ALIS, Antimycobacterial regimen, Omadacycline Oral Tablet, Delpazolid, SPR720, Clofazimine Inhalation Suspension, Ethambutol hydrochloride, Nelfinavir mesylate, Ethambutol hydrochloride, Bedaquiline, and others
• Nontuberculous Mycobacterial Infections Therapeutic Assessment: Nontuberculous Mycobacterial Infections current marketed and Nontuberculous Mycobacterial Infections emerging therapies
• Nontuberculous Mycobacterial Infections Market Dynamics: Nontuberculous Mycobacterial Infections market drivers and Nontuberculous Mycobacterial Infections market barriers

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About DelveInsight

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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