Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Epinephrine HFA-MDI (E004)
Epinephrine HFA-MDI · 1 trial · 1 indication
Bronchodilator effect expressed as AUC of FEV1's relative change from the same day baseline (pre-dose) versus time up to 3 hours, defined as AUC(0-3) of change in FEV1%. The difference of primary endpoints of E004 and Placebo will be evaluated statistically.
| Arm | Type | Description |
|---|---|---|
| Arm T | EXPERIMENTAL | Experimental arm utilizing Epinephrine HFA-MDI (E004) |
| Arm P | PLACEBO_COMPARATOR | Placebo comparator arm utilizing Placebo-HFA |
| Name | Type | Description |
|---|---|---|
| Epinephrine HFA-MDI (E004) | DRUG | Single dose 125 mcg/inhalation, 2 inhalations |
| Placebo-HFA | DRUG | Single dose 0 mcg/inhalation, 2 inhalations |
Inclusion Criteria: * Generally healthy male, and premenarchal female, children ages 4 - 11 years upon Screening. * With documented asthma, requiring inhaled epinephrine or β2-agonist treatment, with or without concurrent anti-inflammatory therapies including orally inhaled corticosteroids, for at ...
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 |
Epinephrine HFA-MDI is an investigational inhaled therapy being developed for asthma. It is delivered as a metered-dose inhaler and is in Phase 3 clinical development. It has not been approved by the FDA and remains under study for the treatment of asthma in pediatric patients.
Epinephrine HFA-MDI targets the alpha and beta adrenergic receptors ADRA1A, ADRA2A, ADRB1, ADRB2, ADRA2C, and ADRA1D. It acts as an agonist at these receptors. This receptor activity is the basis for its development as an inhaled bronchodilator for asthma.
Epinephrine HFA-MDI is being developed by Amphastar Pharmaceuticals, Inc., which trades under the ticker AMPH. The company is the sponsor of the clinical program for this investigational asthma therapy.
Epinephrine HFA-MDI is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 3 trial for this program has been completed.
Epinephrine HFA-MDI has been studied in the Phase 3 trial NCT01737905, titled Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma. This completed trial enrolled 28 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, Epinephrine HFA-MDI is also known as E004. The two names refer to the same investigational product developed by Amphastar Pharmaceuticals for asthma. The Phase 3 trial NCT01737905 used the E004 designation.