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Low dose pilocarpine
Low dose pilocarpine is a Muscarinic receptor agonist Small molecule drug developed by Ocuphire Pharma, Inc.. It is currently in Phase 3 development for Open-angle glaucoma, Ocular hypertension. Also known as: Pilocarpine, LDP.
Low-dose pilocarpine is a muscarinic acetylcholine receptor agonist that stimulates parasympathetic activity to increase aqueous humor outflow and reduce intraocular pressure.
Low-dose pilocarpine is a muscarinic acetylcholine receptor agonist that stimulates parasympathetic activity to increase aqueous humor outflow and reduce intraocular pressure. Used for Open-angle glaucoma, Ocular hypertension.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Low dose pilocarpine |
|---|---|
| Also known as | Pilocarpine, LDP |
| Sponsor | Ocuphire Pharma, Inc. |
| Drug class | Muscarinic receptor agonist |
| Target | Muscarinic acetylcholine receptors (M3, M4) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Pilocarpine binds to muscarinic receptors on the ciliary muscle and trabecular meshwork, causing contraction that mechanically opens drainage pathways for aqueous humor. At low doses, this effect reduces intraocular pressure while minimizing systemic side effects associated with higher pilocarpine concentrations. The drug has been used for decades in ophthalmology, and Ocuphire's formulation aims to optimize efficacy and tolerability for glaucoma management.
Approved indications
- Open-angle glaucoma
- Ocular hypertension
Common side effects
- Miosis (pupil constriction)
- Accommodative spasm (blurred vision)
- Ocular discomfort or irritation
- Headache
- Brow ache
Key clinical trials
- Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia (PHASE3)
- Compound to Control Presbyopia Symptoms (PHASE1)
- Local Pilocarpine for Relieving Dry Mouth (EARLY_PHASE1)
- A Study to Investigate the Effect of Oral Doses of Pilocarpine on Salivary Secretion and Static Pupillometry in Healthy Subjects (PHASE1)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Low dose pilocarpine CI brief — competitive landscape report
- Low dose pilocarpine updates RSS · CI watch RSS
- Ocuphire Pharma, Inc. portfolio CI
Frequently asked questions about Low dose pilocarpine
What is Low dose pilocarpine?
How does Low dose pilocarpine work?
What is Low dose pilocarpine used for?
Who makes Low dose pilocarpine?
Is Low dose pilocarpine also known as anything else?
What drug class is Low dose pilocarpine in?
What development phase is Low dose pilocarpine in?
What are the side effects of Low dose pilocarpine?
What does Low dose pilocarpine target?
Related
- Drug class: All Muscarinic receptor agonist drugs
- Target: All drugs targeting Muscarinic acetylcholine receptors (M3, M4)
- Manufacturer: Ocuphire Pharma, Inc. — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Open-angle glaucoma
- Indication: Drugs for Ocular hypertension
- Also known as: Pilocarpine, LDP
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing