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NEPA
NEPA, marketed by Harrow Eye, is a small molecule drug primarily indicated for post-op ocular inflammation. Its key strength lies in its specific mechanism of action, which targets a unique pathway in the body, potentially offering a differentiated therapeutic profile. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | NEPA |
|---|---|
| Sponsor | Harrow Eye |
| Target | Prostaglandin G/H synthase 1, Prostaglandin G/H synthase 2, Cyclooxygenase |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | FDA-approved |
Approved indications
- Post-Op Ocular Inflammation
- Postoperative Ocular Pain
Common side effects
- Capsular opacity
- Decreased visual acuity
- Foreign body sensation
- Increased intraocular pressure
- Sticky sensation
- Conjunctival edema
- Corneal edema
- Dry eye
- Lid margin crusting
- Ocular discomfort
- Ocular hyperemia
- Ocular pain
Serious adverse events
- Increased bleeding time
- Delayed healing
- Corneal effects
Key clinical trials
- AKY15-HK-301_NEPA Study (PHASE2)
- NEPA in Patients With HER2-positive or HER2-low Advanced Breast Cancer Treated With T-DXd
- Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) (PHASE4)
- A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients (PHASE4)
- Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC) (PHASE2)
- Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer (PHASE4)
- The Safety and Effectiveness of NEPA in Preventing Postoperative Nausea and Vomiting After General Anesthesia Gastrointestinal Cancer Surgery: A Single-Center Retrospective Study
- NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- NEPA CI brief — competitive landscape report
- NEPA updates RSS · CI watch RSS
- Harrow Eye portfolio CI