Pipeline

We are developing a range of products,
primarily for crisis situations

Product Pipeline

Diseases

Registration pathway

Target Submission Date to the FDA

ZEPIZURE® (Midazolam via ZENEO®)

Poisoning

EUA (Emergency Use Authorization)

Early 2025 →

ZEPIZURE® (Midazolam via ZENEO®)

Epilepsy : Status Epilepticus

NDA 505(b2)

Early 2025 →

ZEPIZURE® (Midazolam via ZENEO®)

Epileptic seizures

NDA 505(b2)

Early 2025 →

CJT-L15 (Hydrocortisone via ZENEO®)

Acute adrenal insufficiency crisis

NDA 505(b2)

2026

CJT- L21 (Epinephrine via ZENEO®)

Allergy – Anaphylactic shock

NDA 505(b2)

2026

CJT-L20 (Terbutaline via ZENEO®)

Severe asthma crisis

NDA 505(b2)

2027

CJT-L11 (Sumatriptan via ZENEO®)

Severe migraine - Cluster headache

NDA 505(b2)

2027

CJT-L9 (Methotrexate via ZENEO®)

Chronic rheumatoid arthritis

NDA 505(b2)

2027

CJT-L16 (Naloxone via ZENEO®)

Opioid overdose

NDA 505(b2)

2028

Focus on the three priority products in our portfolio

Globally, approximately 65 million people live with epilepsy, with an estimated 40% experiencing refractory seizures, which remain uncontrolled despite chronic treatments. The economic burden is equally substantial, with the global epilepsy treatment market valued at $10 billion (1) and the U.S. market at $2 billion (2).
In the U.S. alone, over 5,000 epilepsy-related deaths occur annually (3), and seizures account for 3-4.7% of emergency medical services (EMS) calls (4), totaling about 1.9 million annually. Uncontrolled seizures lasting more than 5 minutes significantly increase the risk to neurons and elevate the likelihood of death by 20% (5). Mortality rates for Status Epilepticus rise to 21% within 30 days and 31% over a decade (6). Status Epilepticus is recognized as a rare disease by the FDA and represents a significant unmet medical need.
ZENEO infographic
  • Food Allergy Research & Education (FARE)
  • Everyday Health
  • Moghimi N, Lhatoo SD. Sudden unexpected death in epilepsy or voodoo heart: analysis of heart/brain connections. Curr Cardiol Rep. 2013 Dec;15(12):424.
  • Sapkota S, Caruso E, Kobau R, et al. Seizure- or Epilepsy-Related Emergency Department Visits Before and During the COVID-19 Pandemic — United States, 2019–2021. MMWR Morb Mortal Wkly Rep 2022;71:703–708.
  • Szczurkowska PJ, Polonis K, Becari C, Hoffmann M, Narkiewicz K, Chrostowska M. Epilepsy and hypertension: The possible link for sudden unexpected death in epilepsy? Cardiol J. 2021;28(2):330-335.
  • Logroscino G, Hesdorffer DC, Cascino GD, Annegers JF, Bagiella E, Hauser WA. Long-term mortality after a first episode of status epilepticus. Neurology. 2002 Feb 26;58(4):537-41.

Acute Adrenal Crisis (AAC) is a life-threatening condition classified as a rare disease, with a prevalence of approximately 5 in 10,000 in the U.S. and Europe (1) and over 100,000 cases annually in the U.S. alone (2). Globally, its prevalence stands at 4.9 in 10,000. AAC is characterized by severe symptoms that demand immediate rescue treatment, with the current standard of care being intramuscular (IM) Hydrocortisone.
However, significant challenges remain in managing this condition effectively. Studies indicate that one-third of crisis events occur outside the home (3), with 65% of patients relying on caregiver assistance (3), leading to delays in treatment. Alarmingly, 46% of patients receive Hydrocortisone beyond the recommended time frame, increasing the risk of complications and contributing to an 8% mortality rate (4). Despite its rarity, the U.S. AAC treatment market is valued at $85 million, highlighting the urgent need for improved therapies to address gaps in timely intervention and patient outcomes.
ZENEO Infographic

Anaphylaxis is a severe, life-threatening allergic reaction that requires immediate rescue treatment to prevent fatal outcomes. Affecting an estimated 1 in 20 Americans, with 200,000 cases reported annually in the U.S. (1), its prevalence is increasing, particularly among children. Over the past decade, emergency department visits for anaphylaxis in children have tripled, rising from 11.9 to 35.2 cases per 100,000. Globally, the prevalence stands at 44 cases per 100,000 people (2), with the anaphylaxis treatment market valued at approximately $6 billion (3).
In the U.S., 5.2 million two-pack auto-injectors of intramuscular (IM) epinephrine (4) —the current standard of care—are sold annually. However, challenges remain, including patients with needle phobia or those seeking easier-to-use, needle-free options.