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Also known as E004 (Epinephrine Inhalation Aerosol) HFA-MDI
E004 HFA-MDI · 1 trial · 1 indication
bronchodilator effect expressed as AUC of FEV1's relative change (from the same day baseline) versus time, defined as AUC of ΔFEV1%.
| Arm | Type | Description |
|---|---|---|
| P - Placebo-HFA | PLACEBO_COMPARATOR | Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID |
| T - E004 (Epinephrine Inhalation Aerosol) HFA-MDI | EXPERIMENTAL | E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID |
| Name | Type | Description |
|---|---|---|
| E004 (Epinephrine Inhalation Aerosol) HFA-MDI | DRUG | E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID |
| Placebo-HFA | DRUG | Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID |
Inclusion Criteria: * Generally healthy male, and premenarchal female, children aged 4 - 11 years upon Screening. * With documented asthma, requiring inhaled epinephrine or beta2-agonist treatment, with or without concurrent anti-inflammatory therapies for at least 6-months prior to Screening. * Be...
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 |
E004 HFA-MDI is an investigational epinephrine inhalation aerosol delivered with a hydrofluoroalkane metered-dose inhaler. It is being developed by Amphastar Pharmaceuticals, Inc. as a treatment for asthma. It is a small molecule product in Phase 3 clinical development and is not yet approved.
E004 HFA-MDI is being studied for the treatment of asthma. Its only listed clinical trial enrolled children with asthma, ages 4 years and older, in the United States. The program remains investigational, so the product is not currently an approved asthma therapy.
E004 HFA-MDI is being developed by Amphastar Pharmaceuticals, Inc., which trades under the ticker AMPH. The company is the sponsor of the Phase 3 asthma program for this epinephrine inhalation aerosol product.
E004 HFA-MDI is in Phase 3 clinical development for asthma. Its single listed trial, NCT01460511, is a completed Phase 3 study. Because the program is still in clinical development, E004 HFA-MDI is investigational and has not been approved by the FDA.
E004 HFA-MDI has been evaluated in one clinical trial, NCT01460511, titled Evaluation of Efficacy and Safety of E004 in Children With Asthma. That Phase 3 study was completed, enrolled 70 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States.
Yes. E004 HFA-MDI is also known as E004 (Epinephrine Inhalation Aerosol) HFA-MDI. The two names refer to the same Amphastar Pharmaceuticals product, an epinephrine inhalation aerosol formulated with a hydrofluoroalkane propellant in a metered-dose inhaler and studied for asthma.