NDAORALCAPSULEPriority Review
Approved
Dec 1954
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
8-MOP (methoxsalen) by Bausch + Lomb is ii. Approved for graft versus host disease. First approved in 1954.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
8-MOP (methoxsalen) is an oral psoralen photosensitizer approved in 1954 for graft-versus-host disease (GVHD) and other dermatologic indications. It works by conjugating with DNA upon UVA exposure, forming covalent adducts that trigger inflammatory repair and immunosuppressive mechanisms. The drug is administered orally with subsequent UVA radiation exposure (PUVA therapy), achieving peak blood levels in 1.8 hours with a 2-hour half-life.
LOE Approaching
LOE approaching with minimal linked job activity signals potential team downsizing or transition to maintenance-mode operations at Bausch + Lomb.
Mechanism of Action
II. CLINICAL PHARMACOLOGY The combination treatment regimen of psoralen (P) and ultraviolet radiation of 320-400 nm wavelength commonly referred to as UVA is known by the acronym, PUVA. Skin reactivity to UVA (320–400 nm) radiation is markedly enhanced by the ingestion of methoxsalen. In a well…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.