Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07344558 | A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis | PHASE1 | RECRUITING | 24 | — | — | Dec 22, 2025 | Jun 15, 2026 | May 5, 2026 | 9 | United States |
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 |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| 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 |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP02, AP01 |
| MannKind Corporation | MNKD | 1 | PHASE1 | MNKD-201 |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE1 | NAL |
| AgomAb Therapeutics NV ADR | AGMB | 1 | PHASE1 | AGMB-447 |