COMPANY
MannKind
FDA-approved therapeutic company Clinical Phase 3
Timeline
- Raise Private placement: $50M (total, as published), announced Jul 24, 2026. Source: SEC filing. source ↗
- Trial start 2: Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis source ↗
- Trial start Phase 2: INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes source ↗
- FDA FDA New indication / efficacy supplement: AFREZZA (insulin recombinant human) — BLA022472/27, Jan 23, 2026. Applicant at approval: MannKind Corporation. source ↗
- Trial start Phase 1: A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis source ↗
- Raise Private placement: $500M (up to, as announced), announced Aug 6, 2025. Source: company release on GlobeNewswire. source ↗
- Trial start 3: ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension source ↗
- Trial start Phase 1: A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers source ↗
- Trial start Phase 4: INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes source ↗
- Trial start Phase 4: Afrezza With Basal Combination (ABC): Afrezza® Combined With AID Pump or Insulin Degludec in Adults With Type 1 Diabetes source ↗
- Trial start Phase 3: Afrezza® INHALE-1 Study in Pediatrics source ↗
- Trial start Phase 4: Afrezza® Dosing Optimization Study source ↗
- Trial start Phase 1: Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers source ↗
- Trial start Phase 2: Afrezza Safety and Pharmacokinetics Study in Pediatric Patients source ↗
- Trial start Phase 1: PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM) source ↗
- Trial start Phase 1: Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus source ↗
- Trial start Phase 1: Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers source ↗
- Trial start Phase 1: Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge source ↗
- Trial start Phase 1: Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes source ↗
- Trial start Phase 1: Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C Inhaler source ↗
- Trial start Phase 3: Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus source ↗
- Trial start Phase 3: Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period source ↗
- Trial start Phase 1: Pharmacokinetic Study in Healthy Volunteers source ↗
- Trial start —: Pulmonary Function Substudy for Subjects Enrolled in Studies MKC-TI-161, MKC-TI-162 or MKC-TI-166 source ↗
- Trial start Phase 2: Safety, Immune and Tumor Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma source ↗
Upcoming milestones
- 2027-03 (ESTIMATED) · Phase 2 · INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes · NCT07224321
- Dec 30, 2027 (ESTIMATED) · 2 · Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis · NCT07679893
Funding
Clinical trials (lead sponsor) Showing 50 of 57
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07679893 | Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis | 2 | Recruiting | May 15, 2026 | Dec 30, 2027 (estimated) |
| NCT07224321 | INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes | Phase 2 | Recruiting | Feb 4, 2026 | 2027-03 (estimated) |
| NCT07344558 | A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis | Phase 1 | Completed | Dec 22, 2025 | Jun 17, 2026 (actual) |
| NCT06418711 | ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension | 3 | Terminated | Sep 11, 2024 | Nov 10, 2025 (actual) |
| NCT04974528 | Afrezza® INHALE-1 Study in Pediatrics | Phase 3 | Completed | Sep 29, 2021 | Oct 3, 2024 (actual) |
| NCT05243628 | Afrezza With Basal Combination (ABC): Afrezza® Combined With AID Pump or Insulin Degludec in Adults With Type 1 Diabetes | Phase 4 | Completed | Mar 31, 2022 | Oct 17, 2022 (actual) |
| NCT05904743 | INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes | Phase 4 | Completed | Jul 7, 2023 | Mar 26, 2024 (actual) |
| NCT06532942 | A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers | Phase 1 | Unknown status (ClinicalTrials.gov) | May 28, 2024 | Oct 31, 2024 (estimated) |
| NCT04849845 | Afrezza® Dosing Optimization Study | Phase 4 | Completed | Apr 9, 2021 | May 28, 2021 (actual) |
| NCT02527265 | Afrezza Safety and Pharmacokinetics Study in Pediatric Patients | Phase 2 | Completed | Sep 28, 2017 | Mar 17, 2020 (actual) |
| NCT03464864 | Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers | Phase 1 | Completed | Mar 9, 2018 | Jun 5, 2018 (actual) |
| NCT00642616 | Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease | Phase 3 | Terminated | 2009-03 | 2014-11 (actual) |
| NCT02470637 | Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus | Phase 1 | Completed | 2015-06 | 2015-09 (actual) |
| NCT02485327 | PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM) | Phase 1 | Completed | 2015-07 | 2015-11 (actual) |
| NCT01798914 | Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder | Not listed | No longer available | 2008-10 | 2015-04 (actual) |
| NCT01902121 | Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge | Phase 1 | Completed | 2013-08 | 2013-11 (actual) |
| NCT00642681 | Effects of URI on Diabetic Subjects Utilizing Technosphere Insulin After a Meal Challenge | Not listed | Completed | 2007-12 | 2008-07 (actual) |
| NCT00741429 | A 2-Month Safety Follow-Up Trial | Not listed | Completed | 2007-05 | 2008-09 (actual) |
| NCT01196104 | Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler | Phase 3 | Terminated | 2010-09 | 2011-08 (actual) |
| NCT00747006 | Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake | Phase 2 | Terminated | 2008-09 | 2011-02 (actual) |
| NCT01445951 | Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period | Phase 3 | Completed | 2011-09 | 2013-05 (actual) |
| NCT01451398 | Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus | Phase 3 | Completed | 2011-11 | 2013-06 (actual) |
| NCT00570687 | A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes | Phase 2 | Completed | 2007-09 | 2009-01 (actual) |
| NCT00332488 | Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes | Phase 3 | Completed | 2004-12 | 2008-03 (actual) |
| NCT00308308 | Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes | Phase 3 | Completed | 2006-02 | 2008-07 (actual) |
| NCT00308737 | Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes | Phase 3 | Completed | 2005-06 | 2008-09 (actual) |
| NCT00309244 | Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up | Phase 3 | Completed | 2006-02 | 2008-08 (actual) |
| NCT00700622 | Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks | Phase 3 | Terminated | 2008-05 | 2009-11 (actual) |
| NCT00754624 | An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial | Phase 2 | Completed | 2004-05 | 2008-06 (actual) |
| NCT00662857 | A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin Lispro | Phase 2 | Completed | 2008-04 | 2008-11 (actual) |
| NCT01982604 | Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers | Phase 1 | Completed | 2013-11 | 2014-02 (actual) |
| NCT00626249 | Single Dose, Single Administration Study of Technosphere Inhalation Powder in Diabetic Subjects With Mild or Moderate Kidney Disease Compared to Diabetic Subjects With Normal Kidney Function | Phase 1 | Completed | 2007-08 | 2008-09 (actual) |
| NCT00757367 | A Trial to Determine How Long Insulin and FDKP (the Molecule That Forms Technosphere Particles) Stays in the Lungs of Healthy Individuals After Inhalation of Technosphere® Insulin (TI) Powder Using Bronchoalveolar Lavage (BAL) | Phase 1 | Completed | 2008-07 | 2008-10 (actual) |
| NCT01021891 | A Study to Evaluate Insulin in the Blood After Inhalation of a Dry Powder Insulin Formulation (Called Technosphere®/Insulin) in Non-diabetic Patients With & Without Chronic Obstructive Pulmonary Disease (COPD) | Phase 1 | Completed | 2006-07 | 2008-08 (actual) |
| NCT01544881 | Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes | Phase 1 | Completed | 2012-03 | 2012-09 (actual) |
| NCT01201928 | Pulmonary Function Substudy for Subjects Enrolled in Studies MKC-TI-161, MKC-TI-162 or MKC-TI-166 | Not listed | Terminated | 2010-10 | 2011-03 (actual) |
| NCT01490762 | Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C Inhaler | Phase 1 | Completed | 2011-12 | 2012-05 (actual) |
| NCT00023647 | Vaccine Therapy in Treating Patients With Stage IV Melanoma | Phase 1 | Completed | 2000-07 | 2002-04 (actual) |
| NCT00511979 | Comparison of the Effect on the Glucose Infusion Rates Between Inhaled Technosphere Insulin and a Subcutaneous Injection of Regular Human Insulin | Phase 1 | Completed | 1999-08 | 2000-02 (actual) |
| NCT00642538 | A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes Mellitus | Phase 1 | Completed | 2008-02 | 2008-09 (actual) |
| NCT00475371 | A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males | Phase 1 | Completed | 2007-04 | 2007-06 (actual) |
| NCT01365117 | Pharmacokinetic Study in Healthy Volunteers | Phase 1 | Completed | 2011-01 | 2011-02 (actual) |
| NCT00721344 | A Study to Determine if Technosphere® Inhalation Powder (FDKP) Causes ECG Changes (QTc) Following the Medication's Inhaled Administration. | Phase 1 | Completed | 2008-04 | 2008-08 (actual) |
| NCT00673621 | A Study Designed to Determine if the Pharmacokinetic Disposition of Inhaled Insulin Exposure is the Same for Asthmatics and Non-asthmatics | Phase 1 | Completed | 2008-05 | 2008-11 (actual) |
| NCT00674050 | A Study Designed to Determine if the Drugs Albuterol (Salbutamol) and Fluticasone Have an Effect on the Pharmacokinetics of the Investigational Product Technosphere® Insulin Inhalation Powder in Healthy Volunteers | Phase 1 | Completed | 2008-05 | 2008-09 (actual) |
| NCT01026051 | Safety, Immune and Tumor Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma | Phase 2 | Terminated | 2010-10 | 2011-09 (actual) |
| NCT00332826 | Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma | Phase 3 | Terminated | 2006-06 | 2007-10 (actual) |
| NCT00511602 | Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 Diabetes | Phase 2 | Completed | 2003-12 | 2004-11 (actual) |
| NCT00511732 | 18-Week, Randomized, Double-blind, Placebo Controlled, Forced Titration Study of Patients With Type 2 Diabetes | Phase 2 | Completed | 2004-06 | 2005-08 (actual) |
| NCT00511719 | Bioavailability of Technosphere® Insulin Versus Subcutaneous Regular Human Insulin in Type 2 Diabetes | Phase 2 | Completed | 2004-02 | 2004-04 (actual) |
FDA records (last 2 years)
- FDA New indication / efficacy supplement: AFREZZA (insulin recombinant human) — BLA022472/27, Jan 23, 2026. Applicant at approval: MannKind Corporation. source ↗
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