Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MNKD-201(Nintedanib DPI), Nintedanib Dry Powder Inhalation, Nintedanib Dry
MNKD-201 · 2 trials · 2 indications
Safety and tolerability of different doses and to confirm an optimal dose of Nintedanib Dry Powder Inhalation (DPI)
Events of clinical bronchospasm (e.g., treatment-emergent adverse event \[TEAE\] of wheezing or chest tightness immediately after inhalation)
Change in forced expiratory volume in 1 second (FEV1) (mL)
Change in FEV1/forced vital capacity (FVC) ratio
Rate of study drug discontinuations
Rate of study drug dose reductions
Rate of TEAEs
Rate of treatment-related adverse events (TRAEs)
Rate of serious adverse events (SAEs)
The within-treatment number and proportion of participants with events of bronchospasm (e.g., treatment emergent adverse events \[TEAE\] immediately after inhalation of wheezing or chest tightness)
The within-treatment number and proportion of participants with events of bronchospasm (e.g., treatment emergent adverse events \[TEAE\] immediately after inhalation of wheezing or chest tightness)
The within-treatment number and proportion of participants with changes in FEV1 from pre-dose to any time post-dose
The within-treatment number and proportion of participants with changes in FEV1 from pre-dose to any time post-dose
The within-treatment number and proportion of participants with changes in FEV1/FVC ratio from pre-dose to any time post-dose
The within-treatment number and proportion of participants with changes in FEV1/FVC ratio from pre-dose to any time post-dose
The within-treatment number and proportion of participants with study drug dose discontinuations
The within-treatment number and proportion of participants with study drug dose discontinuations
The within-treatment number and proportion of participants with study drug dose reductions
The within-treatment number and proportion of participants with study drug dose reductions
The within-treatment number and proportion of participants with TEAEs overall and by severity, relationship to study drug, and outcome
The within-treatment number and proportion of participants with TEAEs overall and by severity, relationship to study drug, and outcome
The within-treatment number and proportion of participants with TRAEs overall and by severity and outcome
The within-treatment number and proportion of participants with TRAEs overall and by severity and outcome
The within-treatment number and proportion of participants with SAEs overall and by severity, relationship to study drug, and outcome
The within-treatment number and proportion of participants with SAEs overall and by severity, relationship to study drug, and outcome
| Arm | Type | Description |
|---|---|---|
| Nintedanib DPI 2X day 1st dose | EXPERIMENTAL | Inhalable |
| Placebo 2X day 1st dose | PLACEBO_COMPARATOR | Inhalable |
| Nintedanib DPI 2X day 2nd dose | EXPERIMENTAL | 2nd dose |
| Placebo 2X day 2nd dose | PLACEBO_COMPARATOR | 2nd dose |
| Cohort 1: MNKD-201 Target Dose or placebo | EXPERIMENTAL | Participants will receive a target dose of MNKD-201 (Nintedanib DPI) or placebo, administered via oral inhalation three times daily for 7 days |
| Cohort 2: MNKD-201 High Dose or placebo | EXPERIMENTAL | Participants will receive a high dose of MNKD-201 (Nintedanib DPI) or placebo, administered via oral inhalation twice daily for 7 days |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo across both cohorts of the study |
| Name | Type | Description |
|---|---|---|
| Nintedanib Dry Powder Inhalation | DRUG | Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation. |
| Placebo | DRUG | Placebo oral inhalation powder |
| MNKD-201(Nintedanib DPI) | DRUG | MNKD-201 is a dry powder nintedanib formulation for oral inhalation. |
Inclusion Criteria: * 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 (8...
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MNKD-201 is an investigational inhaled therapy being developed for idiopathic pulmonary fibrosis (IPF), a progressive scarring disease of the lungs. It is a dry powder inhalation formulation of nintedanib delivered directly to the lungs. It is not approved and remains in clinical development.
MNKD-201 is a small molecule inhibitor targeting PDGFRB, PDGFRA, FLT1, FLT4, KDR, and FGFR3. These receptor tyrosine kinases are involved in signaling pathways tied to fibroblast proliferation and angiogenesis, processes relevant to fibrosis. Inhibiting these targets is the intended mechanism of action for the inhaled formulation.
MNKD-201 is being developed by MannKind Corporation, which trades on Nasdaq under the ticker MNKD. MannKind is the sponsor of the clinical program evaluating the inhaled nintedanib dry powder formulation in idiopathic pulmonary fibrosis.
MNKD-201 is in Phase 2 development for idiopathic pulmonary fibrosis. A Phase 1 study has been completed, and a Phase 2 trial is currently recruiting. The drug is investigational and has not been approved by the FDA for any indication.
MNKD-201 has been studied in two trials. NCT07344558 was a completed Phase 1 study of safety, tolerability, and pharmacokinetics in 27 IPF patients in the United States. NCT07679893 is a recruiting Phase 2 trial in 153 IPF patients in Canada. Both enrolled adults aged 40 and older.
Yes. MNKD-201 is also known as nintedanib dry powder inhalation, nintedanib DPI, and nintedanib dry. These names refer to the same MannKind investigational product, an inhaled dry powder formulation of nintedanib being studied in idiopathic pulmonary fibrosis.