Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TD-4208 · 10 trials · 6 indications
To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE)
Weighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline.
TD-4208 Cmax derived from plasma concentration-time curves
| Arm | Type | Description |
|---|---|---|
| TD-4208-1 | ACTIVE_COMPARATOR | 88 mcg |
| TD-4208-2 | ACTIVE_COMPARATOR | 175 mcg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Tiotropium | ACTIVE_COMPARATOR | 18 mcg |
| 44 mcg | EXPERIMENTAL | TD-4208 |
| 88 mcg | EXPERIMENTAL | TD-4208 |
| 175 mcg | EXPERIMENTAL | TD-4208 |
| 350 mcg | EXPERIMENTAL | TD-4208 |
| TD-4208 44 mcg twice daily | EXPERIMENTAL | TD-4208 inhalation solution 44 mcg twice daily for 7 days |
| TD-4208 175 mcg once daily | EXPERIMENTAL | TD-4208 inhalation solution 175 mcg once daily, placebo once daily |
| Dose 1 TD-4208 | EXPERIMENTAL | 22 µg |
| Dose 2 TD-4208 | EXPERIMENTAL | 44 µg |
| Dose 3 TD-4208 | EXPERIMENTAL | 88 µg |
| Dose 4 TD-4208 | EXPERIMENTAL | 175 µg |
| Dose 5 TD-4208 | EXPERIMENTAL | 350 µg |
| Dose 6 TD-4208 | EXPERIMENTAL | 700 µg |
| TD-4208 175 mcg | EXPERIMENTAL | double-blind |
| TD-4208 700 mcg | EXPERIMENTAL | double-blind |
| Placebo for TD-4208 | PLACEBO_COMPARATOR | double-blind |
| Moxifloxacin 400 mg | ACTIVE_COMPARATOR | open-label |
| Renal Impairment | EXPERIMENTAL | Eight subjects with Severe Renal Impairment (eGFR \<30 mL/min/1.73m2). Intervention is TD-4208, 175mcg, inhaled, single dose. |
| Normal Renal Function | EXPERIMENTAL | Eight healthy participants matched to participants with severe renal impairment. Intervention is TD-4208, 175mcg, inhaled, single dose. |
| Hepatic Impairment | EXPERIMENTAL | Eight subjects with Moderate Hepatic Impairment (Child-Pugh B). Drug: TD-4208 175mcg, inhaled, single dose. |
| Normal Hepatic Function | EXPERIMENTAL | Eight healthy participants matched to participants with moderate hepatic impairment. Drug: TD-4208 175mcg, inhaled, single dose. |
| Study Population | EXPERIMENTAL | One dose each of treatments A: \[14C\] TD-4208 20 μg IV administered in a fasted state over 30 minutes. B: \[14C\] TD-4208 200 μg oral solution administered in a fasted state. |
| Name | Type | Description |
|---|---|---|
| TD-4208 | DRUG | - |
| Placebo | DRUG | - |
| Tiotropium | DRUG | There is not a placebo, there is an active comparator (Tiotropium) arm. |
| TD-4208 175 mcg | DRUG | via nebulizer |
| TD-4208 700 mcg | DRUG | via nebulizer |
| Placebo for TD-4208 | DRUG | via nebulizer |
| Moxifloxacin 400 mg | DRUG | oral |
Inclusion Criteria: * Subject is a male or female subject 40 years of age or older Exclusion Criteria: * Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study
TD-4208 is an investigational small molecule being developed for chronic obstructive pulmonary disease (COPD). It has been studied in clinical trials for COPD, including once-daily and twice-daily dosing regimens, as well as in healthy subjects for cardiac repolarization and in patients with renal or hepatic impairment.
TD-4208 is being developed by Viatris Inc., a company traded on the NASDAQ under the ticker symbol VTRS. Viatris has conducted multiple clinical trials of TD-4208 for chronic obstructive pulmonary disease (COPD).
TD-4208 has completed Phase 1, Phase 2, and Phase 3 clinical trials. The most advanced trials were Phase 3 studies for chronic obstructive pulmonary disease (COPD), which have been completed. TD-4208 is not approved and remains an investigational drug in clinical development.
TD-4208 has completed four clinical trials. NCT02109172 was a Phase 2 crossover study in COPD. NCT02512510 was a Phase 3 efficacy study in COPD. NCT02518139 was a Phase 3 safety study in COPD. NCT02772159 was a Phase 1 ADME study in healthy male subjects.
TD-4208 is the investigational code name for revefenacin, a long-acting muscarinic antagonist (LAMA) developed for chronic obstructive pulmonary disease (COPD). It is administered via nebulization and has been studied in Phase 3 trials for maintenance treatment of COPD.
TD-4208 is a long-acting muscarinic antagonist (LAMA) that works by blocking the action of acetylcholine on muscarinic receptors in the airways. This action helps to relax and widen the airways, which can improve breathing in patients with chronic obstructive pulmonary disease (COPD).