Last reviewed 2026-05-30 · How we verify

Epinephrine HFA-MDI (E004)

Amphastar Pharmaceuticals, Inc. · Phase 3 active Small molecule ✓ Verified May 2026

Epinephrine HFA-MDI (E004) is a Sympathomimetic amine / Adrenergic agonist Small molecule drug developed by Amphastar Pharmaceuticals, Inc.. It is currently in Phase 3 development for Acute asthma exacerbation, Anaphylaxis.

Epinephrine is a sympathomimetic amine that binds to alpha and beta adrenergic receptors to produce rapid bronchodilation, increased heart rate, and vasoconstriction.

Epinephrine HFA-MDI (E004) is a small molecule adrenergic receptor agonist used to treat asthma in children. It belongs to the drug class of agonists and is administered via inhalation aerosol.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Epinephrine HFA-MDI (E004)
Sponsor	Amphastar Pharmaceuticals, Inc.
Drug class	Sympathomimetic amine / Adrenergic agonist
Target	Alpha-1 adrenergic receptor, Beta-2 adrenergic receptor
Modality	Small molecule
Therapeutic area	Pulmonary / Emergency Medicine
Phase	Phase 3

Mechanism of action

Epinephrine acts as a non-selective adrenergic agonist, stimulating both alpha-1 and beta-2 adrenergic receptors. In the lungs, beta-2 activation relaxes bronchial smooth muscle and reverses airway obstruction. Alpha-1 activation causes vasoconstriction and reduces mucosal edema, while systemic effects include increased heart rate and blood pressure, making it effective for acute anaphylaxis and severe asthma exacerbations.

Approved indications

Acute asthma exacerbation
Anaphylaxis

Common side effects

Tremor
Tachycardia
Palpitations
Headache
Nervousness
Hypertension

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Epinephrine HFA-MDI (E004) CI brief — competitive landscape report
Epinephrine HFA-MDI (E004) updates RSS · CI watch RSS
Amphastar Pharmaceuticals, Inc. portfolio CI

Frequently asked questions about Epinephrine HFA-MDI (E004)

What is Epinephrine HFA-MDI (E004)?

Epinephrine HFA-MDI (E004) is a Sympathomimetic amine / Adrenergic agonist drug developed by Amphastar Pharmaceuticals, Inc., indicated for Acute asthma exacerbation, Anaphylaxis.

How does Epinephrine HFA-MDI (E004) work?

Epinephrine is a sympathomimetic amine that binds to alpha and beta adrenergic receptors to produce rapid bronchodilation, increased heart rate, and vasoconstriction.

What is Epinephrine HFA-MDI (E004) used for?

Epinephrine HFA-MDI (E004) is indicated for Acute asthma exacerbation, Anaphylaxis.

Who makes Epinephrine HFA-MDI (E004)?

Epinephrine HFA-MDI (E004) is developed by Amphastar Pharmaceuticals, Inc. (see full Amphastar Pharmaceuticals, Inc. pipeline at /company/amphastar-pharmaceuticals-inc).

What drug class is Epinephrine HFA-MDI (E004) in?

Epinephrine HFA-MDI (E004) belongs to the Sympathomimetic amine / Adrenergic agonist class. See all Sympathomimetic amine / Adrenergic agonist drugs at /class/sympathomimetic-amine-adrenergic-agonist.

What development phase is Epinephrine HFA-MDI (E004) in?

Epinephrine HFA-MDI (E004) is in Phase 3.

What are the side effects of Epinephrine HFA-MDI (E004)?

Common side effects of Epinephrine HFA-MDI (E004) include Tremor, Tachycardia, Palpitations, Headache, Nervousness, Hypertension.

What does Epinephrine HFA-MDI (E004) target?

Epinephrine HFA-MDI (E004) targets Alpha-1 adrenergic receptor, Beta-2 adrenergic receptor and is a Sympathomimetic amine / Adrenergic agonist.

Drug class: All Sympathomimetic amine / Adrenergic agonist drugs
Target: All drugs targeting Alpha-1 adrenergic receptor, Beta-2 adrenergic receptor
Manufacturer: Amphastar Pharmaceuticals, Inc. — full pipeline
Therapeutic area: All drugs in Pulmonary / Emergency Medicine
Indication: Drugs for Acute asthma exacerbation
Indication: Drugs for Anaphylaxis

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing