Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tiotropium HFA BAI · 1 trial · 1 indication
To evaluate the PK of Tiotropium Hydrofluoroalkane (HFA) Breath Actuated Inhaler (BAI) (4.5 mcg/day and 9 mcg/day) to SPIRIVA® HandiHaler® and Spiriva® Respimat®
To evaluate the PK of Tiotropium HFA BAI (4.5 mcg/day and 9 mcg/day) to SPIRIVA® HandiHaler® and Spiriva® Respimat®
| Arm | Type | Description |
|---|---|---|
| Treatment ABCD | EXPERIMENTAL | The following treatments are to be studied in a 4-period, crossover design with once daily (QD) dosing for 7 days and at least 21 day washout period between treatments: Treatment A: Tiotropium HFA BAI 4.5 mcg/day Treatment B: Tiotropium HFA BAI 9.0 mcg/day Treatment C: SPIRIVA® HandiHaler® 18 mcg/day Treatment D: Spiriva® Respimat® 5 mcg/day |
| Treatment BDAC | EXPERIMENTAL | The following treatments are to be studied in a 4-period, crossover design with once daily (QD) dosing for 7 days and at least 21 day washout period between treatments: Treatment B: Tiotropium HFA BAI 9.0 mcg/day Treatment D: Spiriva® Respimat® 5 mcg/day Treatment A: Tiotropium HFA BAI 4.5 mcg/day Treatment C: SPIRIVA® HandiHaler® 18 mcg/day |
| Treatment CADB | EXPERIMENTAL | The following treatments are to be studied in a 4-period, crossover design with once daily (QD) dosing for 7 days and at least 21 day washout period between treatments: Treatment C: SPIRIVA® HandiHaler® 18 mcg/day Treatment A: Tiotropium HFA BAI 4.5 mcg/day Treatment D: Spiriva® Respimat® 5 mcg/day Treatment B: Tiotropium HFA BAI 9.0 mcg/day |
| Treatment DCBA | EXPERIMENTAL | The following treatments are to be studied in a 4-period, crossover design with once daily (QD) dosing for 7 days and at least 21 day washout period between treatments: Treatment D: Spiriva® Respimat® 5 mcg/day Treatment C: SPIRIVA® HandiHaler® 18 mcg/day Treatment B: Tiotropium HFA BAI 9.0 mcg/day Treatment A: Tiotropium HFA BAI 4.5 mcg/day |
| Name | Type | Description |
|---|---|---|
| Tiotropium HFA BAI 4.5 mcg | DRUG | - |
| Tiotropium HFA BAI 9.0 mcg | DRUG | - |
| SPIRIVA® HandiHaler® 18 mcg/day | DRUG | - |
| Spiriva® Respimat® 5 mcg/day | DRUG | - |
Inclusion Criteria: 1. Written informed consent signed and dated by the subject before conducting any study related procedure 2. Male or female subjects 40 -80 years of age, as of the Screening Visit 3. Diagnosis of COPD as defined by the GOLD (Global Initiative for Chronic Obstructive Lung Disease...
Top 11 of 14 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 8 | PHASE3 | Depemokimab, GSK5784283, GSK3862995B |
| AstraZeneca PLC | AZN | 14 | PHASE3 | Tezepelumab, Breztri, Bevespi, Tozorakimab, AZD6793 |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Lunsekimig, SAR447537, Dupilumab |
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Ensifentrine, Frespaciguat |
| Pfizer Inc. | PFE | 2 | PHASE3 | Tilrekimig, PF-07275315 |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Alpha-1 MP |
| Hoffmann-La Roche | RHHBY | 4 | PHASE3 | Astegolimab, RO7830698, GDC-6988 |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Generate Biomedicines, Inc. | GENB | 1 | PHASE1 | GB-0895 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | Tyvaso (treprostinil) |
Tiotropium HFA BAI is an investigational small molecule developed by Teva Pharmaceutical Industries Limited (TEVA) for chronic obstructive pulmonary disease, or COPD. It is delivered as a breath-actuated inhaler and is also known as Tiotropium HFA BAI 4.5 mcg. It remains in clinical development and is not an approved product.
Tiotropium HFA BAI is being developed for the treatment of chronic obstructive pulmonary disease (COPD). Its only recorded clinical trial enrolled 36 adults aged 40 years and older with COPD in Germany. Because the program is at Phase 1, the drug has not been established as a treatment for COPD.
Tiotropium HFA BAI targets CHRM3, the M3 muscarinic acetylcholine receptor, and acts as an antagonist at that receptor. Blocking CHRM3 reduces cholinergic signaling in the airways, which is the mechanism underlying this class of inhaled respiratory agents used in COPD.
Tiotropium HFA BAI is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor behind the compound's clinical program in COPD, including the single Phase 1 pharmacokinetic study conducted in Germany.
Tiotropium HFA BAI is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The program has not reached later-stage testing, so the drug is investigational and has not been approved by the FDA or any other regulator.
Tiotropium HFA BAI has been studied in one completed Phase 1 trial, NCT01785433, titled a comparison of the pharmacokinetics of tiotropium in subjects with COPD. It was a randomized, controlled study that enrolled 36 participants aged 40 years and older in Germany. No trials are currently active.