Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TD-8236 · 2 trials · 1 indication
Values are reported as a weighted mean derived by calculating the AUC change from baseline over the relative time interval, divided by the time interval.
| Arm | Type | Description |
|---|---|---|
| TD-8236 Dose A (low dose) | EXPERIMENTAL | TD-8236 Dose A (QD x 14 days) |
| TD-8236 Dose B (high dose) | EXPERIMENTAL | TD-8236 Dose B (QD x 14 days) |
| Placebo | PLACEBO_COMPARATOR | Placebo (QD x 14 days) |
| TD-8236 for SAD (Part A) | EXPERIMENTAL | 6 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive TD-8236 |
| Placebo for SAD (Part A) | PLACEBO_COMPARATOR | 2 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive placebo |
| TD-8236 for MAD (Part B) | EXPERIMENTAL | 6 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive TD-8236. |
| Placebo for MAD (Part B) | PLACEBO_COMPARATOR | 2 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive placebo. |
| TD-8236 for Biomarker (Part C) | EXPERIMENTAL | 8 subjects in each of 2 biomarker cohorts will be randomized to receive TD-8236. |
| Placebo for Biomarker (Part C) | PLACEBO_COMPARATOR | 8 subjects in 1 biomarker cohort will be randomized to receive placebo. |
| Name | Type | Description |
|---|---|---|
| TD-8236 | DRUG | The study drug will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods. |
| Placebo | DRUG | The placebo will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods. |
Inclusion Criteria: * Male or female, 18 to 65 years of age * Willing and able to give informed consent and comply with study requirements * Documented physician-diagnosed asthma for ≥ 4 months prior to Screening * Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening and weighs ≥ 50 kg at Scr...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
TD-8236 is an inhaled small molecule being developed by Theravance Biopharma for the treatment of asthma. It is a JAK inhibitor delivered by inhalation and has been studied in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA.
TD-8236 is being developed as an inhaled treatment for asthma. It is intended to be delivered directly to the airways, and clinical studies have enrolled adults with asthma as well as healthy volunteers. It remains investigational and is not approved for any indication.
TD-8236 targets JAK, a kinase. JAK inhibitors interfere with kinase signaling, and TD-8236 is designed as an inhaled small molecule so the JAK-targeting activity is directed to the lungs. The target class is kinase.
TD-8236 is being developed by Theravance Biopharma, Inc., which trades on Nasdaq under the ticker TBPH. The company is the sponsor of the clinical program evaluating the inhaled JAK inhibitor in asthma.
TD-8236 is in Phase 2 development. Two clinical trials have been completed, one Phase 1 and one Phase 2, with no active trials currently listed. TD-8236 is investigational and has not been approved by the FDA.
TD-8236 has been studied in two completed trials. NCT04150341 was a Phase 2 study of inhaled TD-8236 on allergen-induced asthmatic response in 24 participants in the United Kingdom. NCT03652038 was a Phase 1 single and multiple ascending dose study by inhalation in 94 participants.