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Mannkind Corp. (MNKD)
NASDAQ:MNKD
(Part A) Mknd-201, (Part B) Mknd-201
Healthy Volunteers
Phase I
Recruiting
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers
Jul 26, 2024
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Insulin Degludec, Basal Insulin, Afrezza, Rapid-Acting Insulin Analog
Diabetes Mellitus, Type 1
Phase IV
Completed
INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes
Jun 02, 2023
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Insulin Degludec, Afrezza (Insulin Human) Inhalation Powder, Continuous Subcutaneous Insulin Infusion (Csii) Pump With Automatic Insulin Delivery (Aid)
Type 1 Diabetes
Phase IV
Completed
Afrezza With Basal Combination (ABC): Afrezza® Combined With AID Pump or Insulin Degludec in Adults With Type 1 Diabetes
Feb 07, 2022
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Basal Insulin, Afrezza, Rapid-Acting Insulin Analog
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Phase III
Completed
Afrezza® INHALE-1 Study in Pediatrics
Jun 22, 2021
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Afrezza Dose 1, Afrezza Dose 2
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Phase IV
Completed
Afrezza® Dosing Optimization Study
Apr 16, 2021
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Afrezza Inhalant Product
Type 2 Diabetes Treated With Insulin
Phase IV
Unknown
A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily Injections
Oct 09, 2019
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Treprostinil Inhalation Powder
Pulmonary Arterial Hypertension
Phase I
Completed
Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers
Mar 01, 2018
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Afrezza Plus One Drop | Premium, One Drop | Premium
Diabetes Mellitus, Type 2
Phase IV
Unknown
A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone
Oct 10, 2017
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Afrezza
Type 1 Diabetes Mellitus
Phase II
Completed
Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
Aug 17, 2015
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Mannkind Corp. (MNKD) have in its pipeline
MNKD is currently developing the following drugs: (Part A) Mknd-201, (Part B) Mknd-201, Clofazimine Inhalation Suspension, Insulin Degludec, Basal Insulin, Afrezza, Rapid-Acting Insulin Analog. These drug candidates are in various stages of clinical development as the company works toward FDA approval.