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Phase 2 MNKD-201 (Nintedanib Dry Powder Inhalation) for Idiopathic Pulmonary Fibrosis

This study is testing a new way to give Nintedanib, a medicine for Idiopathic Pulmonary Fibrosis (IPF). Instead of a pill, you would inhale Nintedanib Dry Powder (MNKD-201). Researchers want to see how safe this inhaled medicine is and if it helps improve lung function in people with IPF. You could be eligible if you are 40-80 years old, have IPF, and weigh over 88 pounds. You might be new to IPF treatment or already taking pirfenidone and/or nerandomilast. The study will look at safety, especially breathing problems (bronchospasm events), and changes in your lung function. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study involving 210 participants. You would receive either MNKD-201 or a placebo for 12 weeks, followed by 24 weeks where everyone receives MNKD-201.
What's involved
You would take the study medicine for 12 weeks, followed by an additional 24 weeks of active treatment. The study will measure your safety and how well the treatment works during this time.
Compensation
Not stated in the trial record.
Follow-up
Your safety and lung function will be measured from enrollment until the end of the open-label treatment at 36 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07679893

Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis

Recruiting
PHASE2Ages 40–80InterventionalTreatment
Mannkind Corporation
~153 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:Nintedanib Dry Powder InhalationPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Efficacy
Measured over From enrollment to the end of randomized treatment at 12 weeks
+8 more outcomes measured

Conditions

Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)

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Idiopathic Pulmonary Fibrosis

NCT07679893

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Trial Management Group Inc

    Windsor, Ontario, Canadastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Wassim Fares, MD, SVP, Therapeutic Area Head, Orphan Lung Disease, MD
[email protected]
203-796-3407
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

40-80 years old when signing consent and entering screening.
Diagnosed with IPF based on current ATS/ERS/JRS/ALAT guidelines.
Either new to treatment or on a stable dose of pirfenidone and/or nerandomilast for at least 3 months before screening.
Weighs more than 40 kg (88 lb) at screening.
Women who can become pregnant:
Must have a negative pregnancy test at screening.
Must use an approved birth control method from screening until at least 1 month after the last study dose.
Men who can father a child and are sexually active with women who can become pregnant:
Must use an approved birth control method during treatment and for at least 3 months after the last study dose.
Must not donate sperm during treatment and for at least 3 months after the last study dose.
Willing to follow all study rules and restrictions.
Willing and able to attend study visits and complete study procedures.
Able to perform spirometry (lung function testing) as required by the study.

Exclusion

Has a lung disease caused by something other than IPF.
Has a connective tissue or autoimmune disease (such as lupus, scleroderma, or rheumatoid arthritis).
Has another condition that significantly affects breathing.
Has serious heart or blood vessel disease.
Has a recent or current infection.
Was recently hospitalized for COVID-19, an IPF flare-up, or a lung infection.
Has a history of asthma (except childhood asthma that has resolved).
Has another medical condition or abnormal test result that may affect study participation or safety.
Cannot perform high-quality spirometry testing.
Has obstructive lung disease.
Has abnormal liver function tests.
Has moderate to severe liver disease.
Has severe kidney disease.
Has recently used high-dose steroids or other immune-suppressing medications.
Has active cancer or recent cancer treatment.
Is on, or expected to be added to, a transplant list.
Had major surgery recently or has planned procedures that could interfere with the study.
Has had a severe reaction to nintedanib or cannot take nintedanib safely.
Has recently used certain medications that may interact with the study drug.
Is currently using, or plans to use, prohibited medications during the study.
Has recently participated in another clinical trial.
Has current alcohol or drug abuse issues.
Donated a significant amount of blood recently.
Received a live vaccine recently.
Currently smokes, recently smoked, or quit smoking less than 1 year ago.
Requires more than 6 L/min of oxygen while at rest.

What this trial measures

  • Safety and EfficacyFrom enrollment to the end of randomized treatment at 12 weeks

    Safety and tolerability of different doses and to confirm an optimal dose of Nintedanib Dry Powder Inhalation (DPI)

  • Events of clinical bronchospasmFrom enrollment to the end of open-label treatment at 36 weeks

    Events of clinical bronchospasm (e.g., treatment-emergent adverse event \[TEAE\] of wheezing or chest tightness immediately after inhalation)

  • FEV1 changeFrom enrollment to the end of open-label treatment at 36 weeks

    Change in forced expiratory volume in 1 second (FEV1) (mL)

  • Spirometry Changeenrollment to end of open label at 36 weeks

    Change in FEV1/forced vital capacity (FVC) ratio

  • Study Drug DiscontinuationFrom enrollment to the end of open-label treatment at 36 weeks

    Rate of study drug discontinuations

  • Study Drug Dose ReductionsFrom enrollment to the end of open-label treatment at 36 weeks

    Rate of study drug dose reductions

  • Adverse EventsFrom enrollment to the end of open-label treatment at 36 weeks

    Rate of TEAEs

  • Related Adverse EventsFrom enrollment to the end of open-label treatment at 36 weeks

    Rate of treatment-related adverse events (TRAEs)

  • Serious Adverse EventsFrom enrollment to the end of open-label treatment at 36 weeks

    Rate of serious adverse events (SAEs)