Mycobacterium Infections, Nontuberculous

6
Pipeline Programs
2
Companies
6
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
3
0
3
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Insmed
InsmedBRIDGEWATER, NJ
5 programs
2
3
ALISPhase 31 trial
ALISPhase 31 trial
LAIPhase 31 trial
LAI plus multi-drug regimenPhase 21 trial
Liposomal amikacin for inhalationPhase 21 trial
Active Trials
NCT03038178CompletedEst. Dec 2019
NCT01315236Completed90Est. Jun 2015
NCT04677543Completed99Est. May 2023
+2 more trials
Paratek Pharmaceuticals
1 program
1
Omadacycline Oral TabletPhase 21 trial
Active Trials
NCT04922554Completed66Est. Jul 2024

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
InsmedALIS
InsmedALIS
InsmedLAI
Paratek PharmaceuticalsOmadacycline Oral Tablet
InsmedLAI plus multi-drug regimen
InsmedLiposomal amikacin for inhalation

Clinical Trials (6)

Total enrollment: 1,016 patients across 6 trials

NCT04677569InsmedALIS

Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Start: Apr 2021Est. completion: Jan 2026425 patients
Phase 3Completed
NCT04677543InsmedALIS

Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Start: Dec 2020Est. completion: May 202399 patients
Phase 3Completed
NCT02344004InsmedLAI

Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone

Start: May 2015Est. completion: Apr 2019336 patients
Phase 3Completed
NCT04922554Paratek PharmaceuticalsOmadacycline Oral Tablet

Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)

Start: Oct 2021Est. completion: Jul 202466 patients
Phase 2Completed
NCT03038178InsmedLAI plus multi-drug regimen

Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease

Start: Oct 2016Est. completion: Dec 2019
Phase 2Completed
NCT01315236InsmedLiposomal amikacin for inhalation

Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria

Start: Apr 2012Est. completion: Jun 201590 patients
Phase 2Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

3 late-stage (Phase 3) programs — potential near-term approvals
2 companies competing in this space