NDAOPHTHALMICSOLUTION/DROPS
Approved
Oct 2023
Lifecycle
Growth
Competitive Pressure
0/100
Data completeness
4/8 — Partial
QLOSI (pilocarpine hydrochloride) by Orasis Pharmaceuticals is clinical pharmacology: pharmacodynamics: pilocarpine is a cholinergic parasympathomimetic agent exerting a broad spectrum of pharmacologic effects with predominant muscarinic action. Approved for vaginal dryness. First approved in 2023.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QLOSI is a pilocarpine hydrochloride ophthalmic solution approved October 2023 for vaginal dryness, leveraging a cholinergic parasympathomimetic mechanism to stimulate exocrine gland secretion. The drug is administered as eye drops to enhance fluid production, representing a novel topical approach to a systemic condition. Pilocarpine's broad pharmacodynamic profile includes effects on salivary, lacrimal, and mucous gland secretion, with clinical efficacy demonstrated in head & neck cancer patients and Sjögren's syndrome populations.
Growth11.3 years to LOE
Early-stage growth product with recent FDA approval and extended patent protection; brand team likely building from launch infrastructure with potential for expansion into underserved dryness indications.
Mechanism of Action
CLINICAL PHARMACOLOGY: Pharmacodynamics: Pilocarpine is a cholinergic parasympathomimetic agent exerting a broad spectrum of pharmacologic effects with predominant muscarinic action. Pilocarpine, in appropriate dosage, can increase secretion by the exocrine glands. The sweat, salivary, lacrimal,…
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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.