Also known as: adrenaline, Anaphylm
Epinephrine (adrenaline) is an adrenergic agonist medication used for emergency and acute conditions including anaphylaxis, cardiac arrest, severe asthma/croup settings, and superficial bleeding. It can be administered by multiple routes including intramuscular and intravenous routes, and intranasal formulations are also approved. It is prescription-only in major regions.
Nationwide FDA recalls include generic Adderall XR (mix-up), levothyroxine (subpotent), Gas-X (coolant contamination), and several prescription drugs classed as Class II. Moringa dietary supplements are under Class I recall due to serious health risks. Consumers are advised to check lot numbers and consult pharmacists.
Aquestive Therapeutics disclosed FDA deficiencies in its Anaphylm NDA, halting labeling discussions and causing a 37% stock drop. The setback does not represent a final rejection, leaving a path for resubmission.
Slow up-dosing peanut OIT enabled 82% of toddlers to tolerate 3.5 peanuts after treatment. Low-dose OIT was safe in preschoolers with single or multiple food allergies. Allergist guidance on anxiety was linked to reduced caregiver worry.
Aquestive Therapeutics received a Complete Response Letter from the FDA for Anaphylm (dibutepinephrine) sublingual film, citing deficiencies in human factors validation and packaging. The company plans to resubmit as early as Q3 2026.
CSL Seqirus announced that neffy adrenaline nasal spray has been approved in Australia for emergency treatment of anaphylaxis in adults and children 15kg+ and aged four years and over, marking the first new adrenaline administration method approved in over 30 years.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07775001 |
Dopamine Versus Epinephrine for Pediatric Fluid-Refractory Hypotensive Septic Shock |
ACTIVE_NOT_RECRUITING | NA |
| NCT07733167 |
Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate: Exploring Its Role in Optimizing Surgical Outcomes |
RECRUITING | PHASE3 |
| NCT07667829 |
Vasopressor Agents in Pulmonary Hypertension Crisis |
NOT_YET_RECRUITING | NA |
| NCT07144267 |
Comparison of Milrinone and Epinephrine on TAPSE |
NOT_YET_RECRUITING | NA |
| NCT07092566 |
R.E.C.K vs Exparel in Robotic Nephrectomy |
RECRUITING | PHASE3 |
| NCT06512402 |
Epinephrine Vs Norepinephrine Infusion During Caesarean Delivery |
NOT_YET_RECRUITING | NA |
| NCT06418308 |
Intrathecal Dexmedetomidine vs Epinephrine |
COMPLETED | PHASE4 |
| NCT06416969 |
Regional Lipolysis and Adipocyte Lipolysis Protein Stimulation |
RECRUITING | EARLY_PHASE1 |
| NCT06284434 |
Liposomal Bupivacaine Use in Alveolar Bone Graft Patients |
RECRUITING | PHASE3 |
| NCT06266962 |
Comparing the Efficiency of Two Approaches in Patients at Risk of Developing Intraoperative Floppy Iris Syndrome |
COMPLETED | PHASE4 |
