Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication YUPELRI is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). YUPELRI is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) . FDA label
Also known as Revefenacin Inhalation Solution, TD-4208
Revefenacin · 12 trials · 7 indications
Change from Baseline (Day 1, pre-dose) trough FEV1 on Day 85
Sensitivity analysis results of change from baseline in trough FEV1 (mL) on Day 85 with missing data imputed by last observation carried forward
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurred after the participant has received the study drug.
A serious adverse event (SAE) was defined as any untoward medical occurrence occurring at any dose that resulted in any of the following outcomes: * Death * Life-threatening situation. "Life-threatening" refers to a situation in which the participant was at risk of death at the time of the event; it does not refer to an event which might have caused death if it were more severe * Inpatient hospitalization or prolongation of existing hospitalization * Congenital anomaly in the offspring of a participant who received study drug * Important medical events that may not result in death, be immediately life-threatening, or require hospitalization, could have been considered an SAE when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition A treatment-emergent SAE is an SAE that occurred after the participant has received the study drug.
Clinically significant changes identified based on change from baseline. Vital signs measured included heart rate, systolic blood pressure and diastolic blood pressure.
Clinically relevant changes identified based on change from baseline. Laboratory Measures assessed included hematology and serum.
Clinically relevant changes identified based on change from baseline.
FEV1 = forced expiratory volume at one second
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 |
|---|---|---|
| Revefenacin inhalation solution 175 mcg QD. | EXPERIMENTAL | Revefenacin inhalation solution 175 mcg QD. |
| Placebo inhalation solution QD. | PLACEBO_COMPARATOR | Placebo inhalation solution QD. |
| Period 1: Revefenacin + Formoterol (Sequential) | EXPERIMENTAL | Days 1 to 21: Revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening. |
| Period 2: Revefenacin + Formoterol (Combo Solution) | EXPERIMENTAL | Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening. |
| Period 1: Placebo + Formoterol (Sequential) | PLACEBO_COMPARATOR | Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening. |
| Period 2: Placebo + Formoterol (Combo Solution) | PLACEBO_COMPARATOR | Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening. |
| Revefenacin | EXPERIMENTAL | Active Revefenacin and placebo (in place of Spiriva Handihaler®) |
| Spiriva Handihaler® | ACTIVE_COMPARATOR | Active Spiriva Handihaler® and placebo (in place of Revefenacin) |
| 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 |
| 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 |
|---|---|---|
| Revefenacin 175 mcg in 3 ML Inhalation Solution | DRUG | Revefenacin |
| Placebo inhalation solution QD | DRUG | Placebo |
| Revefenacin | DRUG | Revefenacin is administered via a nebulizer. |
| Placebo | DRUG | Placebo version of Revefenacin is administered via a nebulizer. |
| Formoterol | DRUG | Administered sequentially in both revefenacin and placebo arms using a nebulizer. |
| Spiriva Handihaler® | COMBINATION_PRODUCT | Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device. |
| Placebo for Revefenacin | DRUG | Placebo administered as double blind, double dummy via nebulization. |
| Placebo for Spiriva Handihaler® | DRUG | Placebo administered as double blind, double dummy via Spiriva HandiHaler®. |
| TD-4208 | DRUG | - |
| Tiotropium | DRUG | There is not a placebo, there is an active comparator (Tiotropium) arm. |
Inclusion Criteria: * Key inclusion criteria include: * Males and females of Chinese ethnicity, at least 40 years of age. Females may be of either childbearing or non-childbearing potential. All females of childbearing potential must be using an acceptable, highly effective method of contracepti...
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) |
Revefenacin is used for the treatment of chronic obstructive pulmonary disease (COPD), including moderate to very severe COPD. It is an inhaled small molecule therapy developed for maintenance treatment of this respiratory condition. Clinical studies have evaluated it in adults aged 40 years and older with COPD.
Revefenacin targets CHRM3, the M3 muscarinic acetylcholine receptor, and acts as an antagonist at this receptor. By blocking CHRM3, it is designed to relax airway smooth muscle in the lungs. This makes it a long-acting muscarinic antagonist (LAMA) for inhaled respiratory use in COPD.
Revefenacin is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the company associated with the clinical development program for revefenacin inhalation solution in COPD.
Revefenacin is in Phase 3 clinical development for COPD. It is an investigational therapy and is not described as approved. The Phase 3 program includes completed trials evaluating revefenacin in patients with COPD, including studies in Chinese subjects and studies of peak inspiratory flow rate.
Revefenacin has been studied in completed Phase 3 trials, including NCT05046795 in Chinese subjects with moderate to very severe COPD, NCT03573817 evaluating revefenacin and formoterol in sequence and as a combination, and NCT03095456, a peak inspiratory flow rate study in COPD. These trials enrolled adults aged 40 years and older.
Yes. Revefenacin is also known as revefenacin inhalation solution and revefenacin 175 mcg in 3 mL inhalation solution. These names refer to the same inhaled small molecule therapy developed for COPD, so readers searching any of these terms are looking at the same drug asset.