Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Nintedanib Dry Powder Inhalation
Nintedanib Dry · 1 trial · 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)
| Arm | Type | Description |
|---|---|---|
| Nintedanib DPI 4X day | EXPERIMENTAL | Inhalable |
| Placebo 4X day | PLACEBO_COMPARATOR | Inhalable |
| Nintedanib 2X day | EXPERIMENTAL | Inhalable |
| Placebo 2X day | PLACEBO_COMPARATOR | Inhalable |
| 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 |
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...
| 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 |
Nintedanib Dry is an investigational small molecule being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF). It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is administered as a dry powder inhalation.
Nintedanib Dry targets kinases, as it belongs to the -nib (kinase) class of small molecules. This mechanism is being studied for its potential effect in Idiopathic Pulmonary Fibrosis. The drug is currently in Phase 2 clinical trials.
Nintedanib Dry is being developed by MannKind Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol MNKD. The drug is currently in Phase 2 clinical development for Idiopathic Pulmonary Fibrosis.
Nintedanib Dry is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is recruiting patients with Idiopathic Pulmonary Fibrosis.
Nintedanib Dry is being studied in a Phase 2 clinical trial registered as NCT07679893. This randomized, double-blind, placebo-controlled trial is recruiting 210 participants with Idiopathic Pulmonary Fibrosis in Canada. The trial is currently active and recruiting.
Yes, Nintedanib Dry is also known as Nintedanib Dry Powder Inhalation. The drug is being developed by MannKind Corporation and is currently in Phase 2 clinical trials for Idiopathic Pulmonary Fibrosis.