ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension
Terminated · Phase 3 · NCT06418711
Conditions: MAC Lung Disease, Treatment Refractory MAC Lung Disease, Mycobacterium Infections, Nontuberculous
At a glance
- Research payments reported, 2025
- $2.2M
- U.S. investigators named
- 48
- Sites paid
- 51
- Planned or actual enrollment
- 132
About the trial
- Sponsor
- Mannkind Corporation
- Tested
- Clofazimine Inhalation Suspension (drug), Placebo (drug)
- Dates
- Started 2024-09-11; completion 2025-11-10
- Results posted
- Not yet
This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT)
From ClinicalTrials.gov, last updated 2025-11-12. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Mannkind Corporation reported $2.2M in research payments for this study in 2025 (220 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Bryan Garcia Pulmonology · Birmingham, AL
- Richard A. Belkin, MD Pulmonology · Santa Barbara, CA
- Scott J. Crabtree JR., MD Infectious Disease · Travis Afb, CA
- Catherine Devoe Internal Medicine · San Francisco, CA
- Mohamed A. Fayed, MD Pulmonology · Fresno, CA
- Philip A. Robinson, MD Infectious Disease · Newport Beach, CA
- Stephen Ruoss, M.D. Critical Care Medicine · Stanford, CA
- Rachel Zabner Spielberger, M.D. Infectious Disease · Los Angeles, CA
- Charles L. Daley, MD Pulmonology · Denver, CO
- David Fraulino, D.O. Infectious Disease · Farmington, CT
- Ashley J. Losier, M.D. Pulmonology · New Haven, CT
- Jose A. Lucar, M.D. Infectious Disease · Washington, DC
- Anne E. O'donnell Pulmonology · Washington, DC
- Mohamed I. Ali Eltoum, M.D. Pulmonology · Saint Petersburg, FL
- Francis J. Averill, MD Pulmonology · Clearwater, FL
- Anas Hadeh, MD Pulmonology · Weston, FL
- Susheela Hadigal, M.D. Sleep Medicine · Gainesville, FL
- Shirish K. Kirtane, MD Pulmonology · Altamonte Springs, FL
- Leigh A. Medaris, MD Infectious Disease · Bay Pines, FL
- Chakrapol Sriaroon, M.D. Pulmonology · Tampa, FL
- Jose Medina, MD Pulmonology · Valdosta, GA
- Colin Swenson, M.D. Pulmonology · Atlanta, GA
- Douglas B. Hornick, MD Pulmonology · Iowa City, IA
- Maha A. Assi, MD Infectious Disease · Wichita, KS
- Andreas Schmid, MD Pulmonology · Kansas City, KS
- Poppy Markwell, M.D. Infectious Disease · New Orleans, LA
- John S. Albin, MD, PHD Infectious Disease · Boston, MA
- Elisa Ignatius, M.D., M.SC. Infectious Disease · Baltimore, MD
- Erica S. Herc Infectious Disease · Detroit, MI
- Maryam Mahmood, MD Infectious Disease · Rochester, MN
- Dima Dandachi, M.D Internal Medicine · Columbia, MO
- Mary L. Daniels, M.D., M.P.H. Pulmonology · Chapel Hill, NC
- Trevor C. Van Schooneveld, M.D. Infectious Disease · Omaha, NE
- Amee S. Patrawalla, MD Critical Care Medicine · Newark, NJ
- Ashwin Basavaraj, M.D. Pulmonology · New York, NY
- Christian D. Becker, M.D., PH.D. Pulmonology · New York, NY
- Angela M. Dimango, M.D. Pulmonology · New York, NY
- Carlos R. Salama, M.D. Infectious Disease · Elmhurst, NY
- Janice Wang, M.D. Internal Medicine · New Hyde Park, NY
- Debra L. Powell, M.D. Infectious Disease · West Reading, PA
- Daniel A. Salerno, M.D. Pulmonology · Philadelphia, PA
- Patrick A. Flume, MD Pulmonology · Charleston, SC
- Abhijit A. Raval, MD Critical Care Medicine · Anderson, SC
- Mezgebe Berhe, MD Infectious Disease · Dallas, TX
- Megan S. Devine, MD Pulmonology · Tyler, TX
- Pamela J. Mcshane, M.D. Pulmonology · Tyler, TX
- Mehdi Mirsaeidi, M.D Pulmonology · Austin, TX
- Eric R. Houpt Infectious Disease · Charlottesville, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Brany $170,128
- University of Virginia $125,117
- NYU School of Medicine $123,844
- University of Alabama at Birmingham $110,246
- Memorial Hospital for Cancer and All $110,103
- Johns Hopkins University $98,589
- St Francis Medical Institute $93,617
- Ochsner Medical Center Acute, LA $87,138
- Henry Ford Health Hospital, MI $78,004
- Yale University $55,631
- Kumc $48,469
- Santa Barbara Cottage Hospital, CA $47,569
- Unc $46,860
- Biomedical Research Alliance of New York LLC (brany) $45,408
- Mass General Brigham $42,498
- George Washington University $40,758
- Temple University Hospital, PA $39,551
- Uconn Health Center $38,253
- Cedars-Sinai Medical Center, CA $37,322
- Clinical Site PArtners LLC DBA Csp Orlando $37,198
- National Jewish Health, CO $37,008
- University of Fl $36,310
- Ut Health Science Center $36,000
- Medstar Georgetown University Hospital, DC $35,960
- Mayo Clinic $34,960
- The Regents of UC $33,088
- UCSF Fresno $32,263
- University of Iowa $31,126
- UCSF Medical Center, CA $30,236
- North Florida Foundation for Research & Education $30,220
- Emory University Hospital, GA $27,914
- Musc $27,403
- Usf $26,278
- Columbia University Medical Center $25,478
- Stanford University $24,879
- Rutgers Biomedical and Health Sciences $24,310
- Hoag Memorial Hospital Presbyterian $23,956
- Cleveland Clinic $22,500
- Unehealth $20,845
- Medster Research $20,650
- University of Missouri Health Care, MO $15,165
- North Texas Id Consultants $14,000
- Idc Clinical Research $12,561
- Washington University $12,534
- Pasadena Center for Medical Research $9,650
- Bay Pines Foundation Inc $8,500
- Reading Hospital, PA $7,500
- Anmed Health, SC $7,000
- Biomedical Research Alliance of New York Llc(brany) $4,205
- Clinical Site PArtners LLC DBA Flourish Research $3,256
- New York School of Medicine $405
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.