This section highlights FDA-related milestones and regulatory updates for drugs developed by MannKind (MNKD).
Over the past two years, MannKind has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Afrezza, Clofazimine, and MNKD-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Afrezza (Technosphere Insulin or TI) - FDA Regulatory Timeline and Events
Afrezza (Technosphere Insulin or TI) is a drug developed by MannKind for the following indication: Type 2 (T2D) diabetes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Afrezza (Technosphere Insulin or TI)
- Announced Date:
- June 9, 2025
- Indication:
- Type 2 (T2D) diabetes
Announcement
MannKind Corporation announced that it will showcase inhaled insulin at the American Diabetes Association's (ADA) 85th Scientific Sessions from June 20-23 in Chicago.
AI Summary
MannKind Corporation will present its inhaled insulin at the American Diabetes Association’s 85th Scientific Sessions in Chicago from June 20-23, 2025. The company aims to highlight the latest advancements in inhaled insulin treatment, especially focusing on pediatric use. During the sessions, Dr. Michael J. Haller, a pediatric endocrinology expert, will share key insights from the randomized period of the INHALE-1 clinical trial. His presentation, titled "From Discovery to Treatment – Latest Updates on Inhaled Insulin Treatment," will be part of a "Future Ready" symposium that discusses breakthroughs in pediatric type 1 diabetes care.
MannKind’s booth (#1617) in the Exhibit Hall will also host scientific exchanges with their medical education team, offering further details on the progress of their inhaled insulin therapies. This effort underlines the company’s commitment to improving diabetes treatment options.
Read Announcement- Drug:
- Afrezza (Technosphere Insulin or TI)
- Announced Date:
- March 10, 2025
- Indication:
- Type 2 (T2D) diabetes
Announcement
MannKind Corporation a company focused on the development and commercialization of inhaled therapeutic products and delivery devices for patients with endocrine and orphan lung diseases, will showcase data from recent studies of inhaled insulin across five presentations at the 18th International Conference on Advanced Technologies and Treatments for Diabetes to be held March 19-22 in Amsterdam.
AI Summary
MannKind Corporation will present five sessions on inhaled insulin at the 18th International Conference on Advanced Technologies and Treatments for Diabetes in Amsterdam, from March 19-22, 2025. The presentations will highlight recent positive data from the INHALE-1 pediatric study and the INHALE-3 adult study, reinforcing the potential of inhaled insulin as an effective treatment for diabetes. In these sessions, experts including Dr. Irl B. Hirsch and Dr. Michael J. Haller will discuss new insights into inhaled insulin, its benefits for both children and adults, and how it may offer a sustained treatment option when used alongside basal insulin.
MannKind’s work with Afrezza aims to improve blood sugar control in diabetic patients. The data showcased at the event underscores ongoing efforts to expand safe and effective diabetes treatment options using innovative, inhaled therapeutic products.
Read Announcement- Drug:
- Afrezza (Technosphere Insulin or TI)
- Announced Date:
- December 16, 2024
- Indication:
- Type 2 (T2D) diabetes
Announcement
MannKind Corporation announced six-month results from its Phase 3 INHALE-1 study of Afrezza (insulin human) Inhalation Powder in children and adolescents (aged 4-17 years of age).
AI Summary
MannKind Corporation released six-month results from its Phase 3 INHALE-1 study, which evaluated Afrezza (insulin human) Inhalation Powder in children and adolescents aged 4-17. The open-label, 26‑week trial compared Afrezza with multiple daily injections (MDI) of rapid-acting insulin combined with basal insulin. The main goal was to show that Afrezza was not inferior to MDI in reducing HbA1c levels. Although the full intent-to-treat analysis was affected by one non-adherent participant, a modified analysis excluding this patient confirmed Afrezza’s non-inferiority. The study also found no differences in lung function between the treatment groups, and safety outcomes, including hypoglycemia, were similar. These results mark an important step in expanding treatment options for young people with diabetes. MannKind plans to discuss these findings and a potential supplemental new drug application (sNDA) with the FDA in the first half of 2025.
Read Announcement- Drug:
- Afrezza (Technosphere Insulin or TI)
- Announced Date:
- September 30, 2024
- Indication:
- Type 2 (T2D) diabetes
Announcement
MannKind Corporation announced top-level 30-week results from its Phase 4 INHALE-3 study, in which additional patients living with type 1 diabetes achieved target A1c levels during the extension phase.
AI Summary
MannKind Corporation recently announced the top-level 30-week results from its Phase 4 INHALE-3 study. The study focused on adults with type 1 diabetes and evaluated the use of Afrezza inhaled insulin combined with basal insulin. During the 13-week extension phase, additional patients achieved target A1c levels, indicating improved glycemic control over the prolonged period. Results showed that patients who remained on Afrezza or switched from their usual care insulin regimen were more likely to reach an A1c below 7%, effectively doubling the number of patients reaching this goal compared to earlier study data.
The findings support Afrezza as a promising option for patients aiming to improve their diabetes management. MannKind Corporation emphasized that these encouraging results provide healthcare practitioners with additional evidence of Afrezza’s effectiveness in helping type 1 diabetes patients attain better glycemic outcomes.
Read Announcement
Clofazimine inhalation suspension (MNKD 101) - FDA Regulatory Timeline and Events
Clofazimine inhalation suspension (MNKD 101) is a drug developed by MannKind for the following indication: Nontuberculous mycobacterial (NTM) lung disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Clofazimine inhalation suspension (MNKD 101)
- Announced Date:
- September 18, 2024
- Indication:
- Nontuberculous mycobacterial (NTM) lung disease
Announcement
MannKind Corporation that it has received clearance from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) to initiate the Phase 3 study (ICoN-1) of Clofazimine Inhalation Suspension for the treatment of NTM lung disease.
AI Summary
MannKind Corporation has received clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to start its Phase 3 study (ICoN-1) of Clofazimine Inhalation Suspension for treating non-tuberculous mycobacterial (NTM) lung disease. This significant step will assess the safety and effectiveness of the inhaled formulation as an add-on to standard care for patients struggling with this serious respiratory condition. The global study aims to enroll approximately 230 participants across multiple sites, helping to confirm whether this new treatment can offer a safe, well-tolerated, and effective option for individuals with NTM infections. In addition to the PMDA clearance in Japan, related approvals have been received from health authorities in South Korea and Australia, with approval from Taiwan expected in late 2024. This advancement represents an important milestone in bringing innovative inhaled therapies to patients in need worldwide.
Read Announcement- Drug:
- Clofazimine inhalation suspension (MNKD 101)
- Announced Date:
- September 18, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Nontuberculous mycobacterial (NTM) lung disease
Announcement
MannKind Corporation announced that Clearance to proceed also received from health authorities in South Korea and Australia, with Taiwan expected in 4Q 2024
AI Summary
MannKind Corporation announced that it has received clearance to proceed from health authorities in South Korea and Australia for its global Phase 3 study of Clofazimine Inhalation Suspension to treat nontuberculous mycobacterial (NTM) lung disease. Additionally, authorization is expected from Taiwan in the fourth quarter of 2024. This international expansion builds on the company’s efforts to evaluate the safety and effectiveness of the treatment as part of a registrational trial.
The study will be conducted at more than 100 sites worldwide and aims to enroll approximately 230 participants, ensuring that at least 180 patients are evaluable for efficacy. By obtaining clearance in these new regions, MannKind is taking a significant step toward making innovative treatment options more widely available to patients suffering from serious respiratory infections.
Read Announcement- Drug:
- Clofazimine inhalation suspension (MNKD 101)
- Announced Date:
- April 29, 2024
- Indication:
- Nontuberculous mycobacterial (NTM) lung disease
Announcement
MannKind Corporation 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.
AI Summary
MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for MNKD-101, a clofazimine inhalation suspension. This clearance marks a major step forward as the company prepares to start a Phase 3 study focused on treating nontuberculous mycobacterial (NTM) lung disease. By administering the drug directly to the lungs at a reduced dose, MannKind aims to offer a treatment that may improve dosing accuracy, tolerability, and overall safety compared to traditional oral forms. The Phase 3 trial will evaluate the effectiveness and safety of MNKD-101 in patients with this challenging lung condition. This development could potentially meet a significant and growing medical need, providing hope to patients suffering from NTM lung disease, particularly in regions such as the United States and Asia Pacific.
Read Announcement
MNKD-101 - FDA Regulatory Timeline and Events
MNKD-101 is a drug developed by MannKind for the following indication: For Nontuberculous Mycobacterial Lung Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MNKD-101
- Announced Date:
- May 6, 2024
- Indication:
- For Nontuberculous Mycobacterial Lung Disease
Announcement
MannKind Announced The FDA Fast Track Designation For Clofazimine Inhalation Suspension (MNKD-101) For Nontuberculous Mycobacterial Lung Disease
AI Summary
MannKind Corporation recently announced that the U.S. FDA has granted Fast Track designation for its new Clofazimine Inhalation Suspension (MNKD-101). This treatment is designed for patients with nontuberculous mycobacterial (NTM) lung disease—a serious condition that can lead to reduced lung function and a lower quality of life, especially for those with underlying respiratory issues.
The Fast Track status is meant to speed up the development and review process by the FDA for medicines that address important unmet medical needs. MannKind sees this as an opportunity to potentially bring a valuable treatment to patients experiencing NTM lung disease sooner. The company also highlighted that the ICoN-1 study, a multinational clinical trial evaluating MNKD-101’s safety and effectiveness when added to standard therapy, is scheduled to begin in June 2024 in the U.S., with plans to expand internationally later in the year.
Read Announcement
