Pilocarpine
Isopto Carpine, Pilo, Qlosi, Salagen, Vuity (pilocarpine) is a small molecule pharmaceutical. Pilocarpine was first approved as Ocusert pilo-20 on 1982-01-01. It is used to treat angle-closure glaucoma, head and neck neoplasms, mydriasis, and xerostomia in the USA. The pharmaceutical is active against muscarinic acetylcholine receptor M3. In addition, it is known to target muscarinic acetylcholine receptor M2, muscarinic acetylcholine receptor M5, muscarinic acetylcholine receptor M1, and muscarinic acetylcholine receptor M4.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| stomatognathic diseases | D009057 |
| eye diseases | D005128 |
Trade Name
FDA
EMA
Isopto carpine, Pilocarpine, Salagen, Vuity (discontinued: Ocusert pilo, Pilopine hs)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pilocarpine hydrochloride
Pilocarpine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OCUSERT PILO-20 | Epic Pharma | N-017431 DISCN | 1982-01-01 | 1 products |
| OCUSERT PILO-40 | Epic Pharma | N-017548 DISCN | 1982-01-01 | 1 products |
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Betaxolol hydrochloride
+
Pilocarpine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BETOPTIC PILO | Alcon Research | N-020619 DISCN | 1997-04-17 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| betoptic pilo | 2006-06-19 | |
| pilocarpine | unapproved drug other | 2011-12-02 |
| pilocarpine hydrchloride | ANDA | 2024-05-31 |
| pilocarpine hydrochloride | NDA authorized generic | 2026-01-23 |
| pilocarpine hydrochloride ophthalmic | ANDA | 2025-06-02 |
| qlosi | New Drug Application | 2025-05-30 |
| salagen | New Drug Application | 2024-12-05 |
| vuity | New Drug Application | 2023-03-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| head and neck neoplasms | — | D006258 | — |
| xerostomia | — | D014987 | K11.7 |
| angle-closure glaucoma | — | D015812 | — |
| mydriasis | — | D015878 | H57.04 |
| hypertension | EFO_0000537 | D006973 | I10 |
| open-angle glaucoma | EFO_0004190 | D005902 | H40.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PILOCARPINE HYDROCHLORIDE, VUITY, ABBVIE | |||
| 2026-03-28 | D-187 | ||
| 2024-10-28 | NP | ||
ATC Codes
N: Nervous system drugs
— N07: Other nervous system drugs in atc
— N07A: Parasympathomimetics
— N07AX: Other parasympathomimetics in atc
— N07AX01: Pilocarpine
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01E: Antiglaucoma preparations and miotics
— S01EB: Parasympathomimetics, antiglaucoma preparations and miotics
— S01EB01: Pilocarpine
— S01EB51: Pilocarpine, combinations
HCPCS
No data
Clinical
Clinical Trials
76 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Presbyopia | D011305 | — | H52.4 | 5 | 3 | 12 | 1 | 1 | 22 |
| Xerostomia | D014987 | — | K11.7 | 1 | 1 | 3 | 2 | 6 | 12 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | 2 | 2 | 7 | 11 |
| Open-angle glaucoma | D005902 | EFO_0004190 | H40.1 | — | — | 1 | 1 | 5 | 7 |
| Dry eye syndromes | D015352 | — | H04.12 | — | 1 | 1 | 1 | 1 | 4 |
| Angle-closure glaucoma | D015812 | — | — | — | — | — | 1 | 2 | 3 |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | — | 1 | 1 | — | 2 |
| Anisocoria | D015875 | — | H57.02 | — | — | — | 1 | — | 1 |
| Eyeglasses | D005139 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ocular hypertension | D009798 | EFO_1001069 | H40.0 | — | — | 2 | — | 5 | 7 |
| Exfoliation syndrome | D017889 | EFO_0004235 | — | — | — | 1 | — | 3 | 4 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | 1 | 1 | — | 1 | 3 |
| Head and neck neoplasms | D006258 | — | — | — | 1 | 3 | — | — | 3 |
| Pseudophakia | D019591 | — | — | 1 | — | 1 | — | — | 2 |
| Cataract | D002386 | EFO_0001059 | H26.9 | — | — | 1 | — | 1 | 2 |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | — | — | 1 | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | — | 1 | — | — | 1 |
| Mucositis | D052016 | EFO_1001898 | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myopia | D009216 | EFO_0003927 | H52.1 | 1 | 1 | — | — | 1 | 2 |
| Eye diseases | D005128 | EFO_0003966 | H44 | — | 1 | — | — | 1 | 2 |
| Hyperopia | D006956 | EFO_0006310 | H52.0 | 1 | 1 | — | — | — | 1 |
| Keratoconjunctivitis | D007637 | — | H16.2 | — | 1 | — | — | — | 1 |
| Conjunctivitis | D003231 | — | H10 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Miosis | D015877 | — | H57.03 | 1 | — | — | — | 1 | 2 |
| Urinary incontinence | D014549 | — | R32 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 3 | 3 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 2 | 2 |
| Syndrome | D013577 | — | — | — | — | — | — | 2 | 2 |
| Keratoconus | D007640 | EFO_0004223 | H18.6 | — | — | — | — | 2 | 2 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 1 | 1 |
| Fibrosis | D005355 | — | — | — | — | — | — | 1 | 1 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | — | 1 | 1 |
| Staphylococcal infections | D013203 | — | A49.01 | — | — | — | — | 1 | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | — | 1 | 1 |
| Postoperative cognitive complications | D000079690 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pilocarpine |
| INN | — |
| Description | (+)-pilocarpine is the (+)-enantiomer of pilocarpine. It has a role as an antiglaucoma drug. It is an enantiomer of a (-)-pilocarpine. |
| Classification | Small molecule |
| Drug class | tricyclic compounds |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@@H]1C(=O)OC[C@@H]1Cc1cncn1C |
Target
Agency Approved
No data
Alternate
CYP2A6
CYP2A6
Organism
Homo sapiens
Gene name
CYP2A6
Gene synonyms
CYP2A3
NCBI Gene ID
Protein name
cytochrome P450 2A6
Protein synonyms
1,4-cineole 2-exo-monooxygenase, Coumarin 7-hydroxylase, CYPIIA6, Cytochrome P450 IIA3, Cytochrome P450(I), cytochrome P450, family 2, subfamily A, polypeptide 6, cytochrome P450, subfamily IIA (phenobarbital-inducible), polypeptide 6, flavoprotein-linked monooxygenase, xenobiotic monooxygenase
Uniprot ID
Mouse ortholog
—
—
Variants
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Estimated US medical usage
Pilocarpine
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Epinephrine
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Pilocarpine
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Trends
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Safety
Black-box Warning
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Adverse Events
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2,128 adverse events reported
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