Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MNKD-201 · 1 trial · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| MNKD-201(Nintedanib DPI) | DRUG | MNKD-201 is a dry powder nintedanib formulation for oral inhalation. |
| Placebo | DRUG | The placebo control in this study is an empty cartridge without any powder. |
Inclusion Criteria: 1. Is ≥40 to ≤85 years of age at the time of signing the informed consent form. 2. Diagnosis of IPF 3. Either treatment-naive or is currently on background pirfenidone or nerandomilast on a stable dose for at least 3 months prior to Screening. 4. Has FVC \>45% of predicted of no...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | HEC585, Pirfenidone |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP01 |
MNKD-201 is an investigational small molecule being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a chronic and progressive lung disease. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
MNKD-201 is being developed by MannKind Corporation, a biopharmaceutical company listed on the NASDAQ under the ticker symbol MNKD. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational drug.
MNKD-201 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by the FDA or any other regulatory agency, and further clinical studies would be needed to establish its safety and efficacy.
MNKD-201 has been studied in one completed Phase 1 clinical trial, identified as NCT07344558. This randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, and pharmacokinetics of MNKD-201 in 27 patients with Idiopathic Pulmonary Fibrosis in the United States.
MNKD-201 is the primary name for this investigational drug candidate. No alternative names have been disclosed in the available clinical trial information, and it is distinct from other drugs in MannKind's pipeline.