Technosphere Insulin

also known as Afrezza · Technosphere() inhaled insulin

Developed for: type 2 diabetes mellitus · type 1 diabetes mellitus · gestational diabetes
Investigated by: Mannkind Corporation · Jaeb Center for Health Research

Trials 19

today NCT07224321 · Ph 2 NCT06535789 · Ph 2/3 NCT01902121 · Ph 1 NCT01490762 · Ph 1 NCT01451398 · Ph 3 NCT01445951 · Ph 3 NCT01196104 · Ph 3 NCT00642616 · Ph 3 NCT00700622 · Ph 3 NCT00662857 · Ph 2 NCT00570687 · Ph 2 NCT00332826 · Ph 3 NCT00308308 · Ph 3 NCT00309244 · Ph 3 NCT00539890 · Ph 3 NCT00539396 · Ph 2 NCT00332488 · Ph 3 NCT00511719 · Ph 2 NCT00511979 · Ph 1

199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 13 trials
Phase 1	NCT01902121	Aug → Nov 2013	—	Mannkind Corporation	Completed	No outcome recorded
Phase 1	NCT01490762	Dec 2011 → May 2012	—	Mannkind Corporation	Completed	No outcome recorded
Phase 1	NCT00511979	Aug 1999 → Feb 2000	—	Mannkind Corporation	Completed	No outcome recorded
Phase 25 trials · 1 met primary
Phase 2	NCT07224321	Feb 2026 → Mar 2027 expected	type 1 diabetes mellitus	Mannkind Corporation	Recruiting	No outcome recorded
Phase 2	NCT00662857	Apr → Nov 2008	type 1 diabetes mellitus	Mannkind Corporation	Completed	No outcome recorded
Phase 2	NCT00570687	Sep 2007 → Jan 2009	type 2 diabetes mellitus	Mannkind Corporation	Completed	No outcome recorded
Phase 2	NCT00539396	Mar → Dec 2005	type 1 diabetes mellitus	Mannkind Corporation	Completed	Met primary
Phase 2	NCT00511719	Feb → Apr 2004	type 2 diabetes mellitus	Mannkind Corporation	Completed	No outcome recorded
Phase 2/31 trial
Phase 2/3	NCT06535789	May → Jul 2025 overdue	gestational diabetes	Jaeb Center for Health Research	Recruiting	No outcome recorded
Phase 310 trials · 4 met primary · 1 missed
Phase 3	NCT01451398	Nov 2011 → Jun 2013	type 2 diabetes mellitus	Mannkind Corporation	Completed	Met primary
Phase 3	NCT01445951	Sep 2011 → May 2013	type 1 diabetes mellitus	Mannkind Corporation	Completed	Met primary
Phase 3	NCT01196104	Sep 2010 → Aug 2011	type 2 diabetes mellitus	Mannkind Corporation	Terminated	No outcome recorded Stop: Business
Phase 3	NCT00642616	Mar 2009 → Nov 2014	asthma, chronic obstructive pulmonary disease, type 1 diabetes mellitus, type 2 diabetes mellitus	Mannkind Corporation	Terminated	No outcome recorded
Phase 3	NCT00700622	May 2008 → Nov 2009	type 1 diabetes mellitus	Mannkind Corporation	Terminated	Met primary
Phase 3	NCT00332826	Jun 2006 → Oct 2007	asthma, type 1 diabetes mellitus, type 2 diabetes mellitus	Mannkind Corporation	Terminated	No outcome recorded Stop: Business
Phase 3	NCT00308308	Feb 2006 → Jul 2008	type 1 diabetes mellitus	Mannkind Corporation	Completed	No outcome recorded
Phase 3	NCT00309244	Feb 2006 → Aug 2008	type 2 diabetes mellitus	Mannkind Corporation	Completed	Met primary
Phase 3	NCT00539890	Nov 2005 → Jul 2006	type 2 diabetes mellitus	Mannkind Corporation	Completed	No outcome recorded
Phase 3	NCT00332488	Dec 2004 → Mar 2008	type 2 diabetes mellitus	Mannkind Corporation	Completed	Missed primary

Press releases naming this drug 77 releases

Date	Issuer	Release
2026-06-23	Mannkind Corporation	MannKind Awarded Breakthrough T1D Grant to Support Advancement of INHALE-1ST Pediatric Trial of Afrezza® in Youth with Newly-Diagnosed T1D mannkindcorp.com ↗
2026-06-05	Mannkind Corporation	Data at ADA 2026 Highlights Key Findings from Clinical and Real‑World Studies of MannKind’s Afrezza® (Inhaled Insulin) Across Pediatric Care, Pregnancy, and Use with Automated Insulin Delivery (AID) Systems mannkindcorp.com ↗
2026-05-29	Mannkind Corporation	MannKind to Host Conference Call Today to Discuss Afrezza Pediatric Approval mannkindcorp.com ↗
2026-05-29	Mannkind Corporation	MannKind Announces FDA Approval of Afrezza®, the First and Only Inhaled Mealtime Insulin for Use in Children and Adolescents Aged 6 and Older Living with Diabetes mannkindcorp.com ↗
2026-05-27	Mannkind Corporation	MannKind to Showcase New Data at ADA 2026 Advancing Understanding of Inhaled Insulin (Afrezza®) in Pediatric Care, Pregnancy and Use with Automated Insulin Delivery (AID) Systems mannkindcorp.com ↗
2026-03-09	Mannkind Corporation	MannKind to Present New Data From Pediatric and Adult Studies of Afrezza® at ATTD 2026 mannkindcorp.com ↗
2026-02-09	Mannkind Corporation	MannKind Announces First Patient Enrolled in INHALE-1ST Pediatric Study Evaluating Afrezza® for Youth with Newly-Diagnosed Type 1 Diabetes (T1D) mannkindcorp.com ↗
2026-01-26	Mannkind Corporation	MannKind Announces FDA Approval of Updated Afrezza® Label Providing Starting Dose Guidance when Switching from Multiple Daily Injections (MDI) or Insulin Pump Mealtime Therapy mannkindcorp.com ↗
2025-10-13	Mannkind Corporation	MannKind Announces U.S. FDA Accepts for Review its Supplemental Biologics License Application (sBLA) for Inhaled Insulin (Afrezza) in Children and Adolescents Aged 4-17 Years Living with Diabetes mannkindcorp.com ↗
2025-06-09	Mannkind Corporation	MannKind to Highlight Data from Recent Pediatric and Adult Studies of Inhaled Insulin (Afrezza®) at American Diabetes Association’s 85th Scientific Sessions in Chicago, June 20-23 mannkindcorp.com ↗
2025-03-10	Mannkind Corporation	MannKind Showcases Efficacy, Safety, and Mealtime Control Data from Recent Pediatric and Adult Studies of Afrezza® at the ATTD Conference, March 19-22 mannkindcorp.com ↗
2024-12-16	Mannkind Corporation	MannKind Announces Six-Month Results From Phase 3 INHALE-1 Pediatric Diabetes Trial Utilizing Inhaled Insulin (Afrezza®) mannkindcorp.com ↗
2024-12-11	Mannkind Corporation	CDSCO Approves Afrezza® (insulin human) Inhalation Powder in India mannkindcorp.com ↗
2024-03-11	Mannkind Corporation	INHALE-3 Study’s Initial Meal Challenge Results Comparing Afrezza® Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps mannkindcorp.com ↗
2024-02-15	Mannkind Corporation	MannKind Announces Enrollment Goal Completion of INHALE-1 Pediatric Diabetes Trial Utilizing Afrezza® mannkindcorp.com ↗
2023-02-22	Mannkind Corporation	MannKind to Give Oral Presentation on Meal Challenge Results From the Afrezza® With Basal Combination (ABC Study) at 16th Annual ATTD Conference mannkindcorp.com ↗
2021-10-04	Mannkind Corporation	MannKind Announces First Patient Enrolled in INHALE-1 Study of Afrezza® in Pediatric Population mannkindcorp.com ↗
2021-06-28	Mannkind Corporation	Policy Change Allows Approval For Medicare Patients Living With Diabetes To Use Both Afrezza® And Continuous Glucose Monitoring Devices Beginning July 18 mannkindcorp.com ↗
2020-06-15	Mannkind Corporation	MannKind Presents Positive Original Analyses of Afrezza® Clinical Data at American Diabetes Association (ADA) 80th Scientific Sessions mannkindcorp.com ↗
2020-06-13	Mannkind Corporation	Investigator-Initiated Study Shows Switching to Afrezza® Improves Glucose Control with No Additional Hypoglycemia in T2DM mannkindcorp.com ↗
2020-01-06	Mannkind Corporation	Afrezza® (insulin human) Inhalation Powder Receives Pricing Registration in Brazil Commercial activities to commence this month mannkindcorp.com ↗
2019-12-20	Mannkind Corporation	Study 171 Shows Hypoglycemia is Reduced with Use of Afrezza® Relative to Insulin Aspart in Type 1 Diabetes mannkindcorp.com ↗
2019-09-19	Mannkind Corporation	MannKind Presents Positive Afrezza® Clinical Data from Type 1 Diabetes Study at 55th Annual Meeting of the EASD mannkindcorp.com ↗
2019-07-31	Mannkind Corporation	Afrezza® Safety and Pharmacokinetics Study in Pediatric Patients Opens Enrollment for Cohort 3 mannkindcorp.com ↗
2019-06-09	Mannkind Corporation	MannKind Presents Positive Afrezza® Clinical Data from Three Studies at ADA 79th Scientific Sessions mannkindcorp.com ↗
2019-06-03	Mannkind Corporation	Afrezza® (insulin human) Inhalation Powder Approved in Brazil mannkindcorp.com ↗
2019-05-16	Mannkind Corporation	MannKind Announces Afrezza® Distribution Agreement in Australia mannkindcorp.com ↗
2019-01-16	Mannkind Corporation	MannKind Announces Direct Purchase Insulin Program Providing Afrezza® for as low as $4 a Day mannkindcorp.com ↗
2018-10-15	Mannkind Corporation	Afrezza® Inhaled Insulin Television Advertising Campaign Wins Gold Award for Creativity mannkindcorp.com ↗
2018-10-04	Mannkind Corporation	MannKind Presents Positive Afrezza® STAT Study Clinical Data at 54th Annual Meeting of the European Association for the Study of Diabetes mannkindcorp.com ↗
2018-09-24	Mannkind Corporation	MannKind Announces Completion of Cohort 1 and Opens Enrollment for Cohort 2 of Afrezza® Safety and Pharmacokinetics Study in Pediatric Patients mannkindcorp.com ↗
2018-09-13	Mannkind Corporation	Positive Afrezza® Clinical Data from STAT Study Published in Diabetes Technology & Therapeutics mannkindcorp.com ↗
2018-07-27	Mannkind Corporation	MannKind and Tanner Pharma Group Enter into an ex-U.S. Distribution Agreement for Afrezza® mannkindcorp.com ↗
2018-06-25	Mannkind Corporation	Additional Positive Afrezza® Clinical Data from STAT Study To Be Presented at ADA 78th Scientific Sessions mannkindcorp.com ↗
2018-06-23	Mannkind Corporation	MannKind Presents Positive Afrezza® Clinical Data from STAT and AFFINITY Studies at ADA 78th Scientific Sessions mannkindcorp.com ↗
2018-05-09	Mannkind Corporation	MannKind and Cipla Enter an Exclusive Marketing and Distribution Agreement for Afrezza® in India mannkindcorp.com ↗
2018-04-25	Mannkind Corporation	FDA Determines that Afrezza REMS Communication Plan Has Met Goals and REMS No Longer Necessary mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	Type 1 Diabetes Patients Using AFREZZA Have More Positive View of Therapy Compared to Standard Insulin Therapy mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	Study Shows AFREZZA(R) Controls Blood Sugar Levels in Type 1 Diabetes, Results in Weight Loss, Less Hypoglycemia Than Usual Care mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	Studies Show No Increased Risk of Cardiac Events in Diabetes Patients Treated with AFREZZA(R) mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	Sanofi and MannKind Announce Global Licensing Agreement for Afrezza® (insulin human) Rapid-Acting Inhaled Insulin mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	Sanofi and MannKind Announce Afrezza®, the Only Inhaled Insulin, Now Available in the U.S. mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Updates Status of New Drug Application for AFREZZA(R) mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Updates Status of New Drug Application for AFREZZA(R) mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Triples Production Capacity for Afrezza mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Resubmits New Drug Application to U.S. FDA for AFREZZA for the Treatment of Adults with Diabetes mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Responds to Hurricane Harvey Devastation with Afrezza® Donation mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 2 Diabetes mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Reports Positive Data from a Phase 3 Clinical Study of Technosphere Insulin in Type 1 Diabetes mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Regains Afrezza® Marketing Rights mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind to Manufacture 12 Unit Cartridge Strength of AFREZZA(R) Following FDA Approval mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Donates Afrezza® to Support People with Diabetes Impacted by Hurricane Maria in Puerto Rico mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind to Discuss U.S. Commercialization Update for Afrezza® mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Corporation Receives Complete Response Letter from the FDA for AFREZZA(R) mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Corporation Providing AFREZZA(R) to Juvenile Diabetes Research Foundation for Artificial Pancreas Project mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Corporation Announces FDA Approval of AFREZZA(R); A Novel, Rapid-Acting Inhaled Insulin for the Treatment of Diabetes mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Completes Phase 3 Clinical Study of AFREZZA in Patients with Type 2 Diabetes mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Completes Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Completes Patient Recruitment in Two Phase 3 Clinical Studies of AFREZZA mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	Mannkind Assumes Responsibility for Distribution of Afrezza® and Launches Patient Reimbursement and Adherence Support Programs mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Announces Tentative Date of FDA Advisory Committee Review of AFREZZA mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Announces Positive Clinical Data for AFREZZA; Both AFFINITY Phase 3 Studies Meet Primary Endpoints mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Announces Launch of New Titration Pack and Field Force Expansion to Accelerate Afrezza® Growth mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind Announces FDA Acknowledgement of Resubmission of New Drug Application for AFREZZA mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind and Sanofi Reach Agreement on AFREZZA® mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	MannKind and Biomm Enter Into Distribution Agreement for Afrezza in Brazil mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	Follow-up Safety Data Show AFREZZA(R) Comparable to Standard Antidiabetic Therapy in Lung Function Tests mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	FDA Updates Afrezza® Prescribing Information mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	FDA Requests Additional Information Regarding AFREZZA(TM) in Complete Response Letter to MannKind mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	FDA Advisory Committee Recommends Approval of AFREZZA(R), MannKind Corporation's Investigational Drug to Treat Diabetes mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	FDA Accepts AFREZZA Complete Response Resubmission and Sets Target Action Date mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	CORRECTING and REPLACING MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	American Diabetes Association/The Lancet Symposium Will Highlight Study Showing AFREZZA(R) Provides Comparable Glycemic Control with Less Weight Gain and Hypoglycemia than Standard of Care mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	AFREZZA(R) Suppresses Endogenous Glucose Production More Rapidly Than Currently Available Insulin Therapy mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	AFREZZA® Demonstrates Long-Term Efficacy in Controlling Blood Sugar Levels in Patients with Type 2 Diabetes mannkindcorp.com ↗
2017-10-30	Mannkind Corporation	AFREZZA Demonstrates Non-Inferiority Compared to Standard Therapy in Controlling Blood Sugar Levels in Type 1 Diabetes Patients mannkindcorp.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 21 sources stand behind the page.

Field	Value	Cited text
Known as	Technosphere/Insulin	“AIM: To evaluate the effect of final HbA1c levels on the incidences of hypoglycaemia in participants with type 1 diabetes treated with inhaled Technosphere® Insulin or...” PMID 31811662 ↗ Dec 2019 24 “A 3 Month, Randomized, Open Label, Multi-center Study of Technosphere/Insulin Compared to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Receiving Insulin Glargine” NCT00539396 ↗ “Technosphere® Insulin inhalation powder (TI) is an ultra-rapid-acting insulin administered via oral inhalation using a breath-powered inhaler.” NCT06535789 ↗ “Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial.” PMID 26180109 ↗ Jul 2015 “Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone” NCT00332488 ↗ “Bioavailability of Technosphere® Insulin Versus Subcutaneous Regular Human Insulin in Type 2 Diabetes” NCT00511719 ↗ “Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basal” NCT00308308 ↗ “Technosphere Insulin® Inhalation Powder” NCT00662857 ↗ NCT01490762 ↗ NCT01196104 ↗ NCT01902121 ↗ Show 14 more sources
Known as	Afrezza	“Patients will receive TI (Afrezza) to be compared to RAA following a breakfast meal” NCT06535789 ↗
Known as	Technosphere() inhaled insulin	“Technosphere(®) inhaled insulin (MannKind Corp., Valencia, CA)” PMID 21999640 ↗ Oct 2011
Modality	Protein / enzyme biologic	“It consists of recombinant human insulin adsorbed onto fumaryl diketopiperazine (FDKP), a proprietary excipient” NCT06535789 ↗
Route	Inhaled	“Inhalation, 15U/30U, prandial” NCT00332488 ↗