Pilocarpine
Isopto Carpine, Pilo, 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 M4, muscarinic acetylcholine receptor M1, muscarinic acetylcholine receptor M5, and cytochrome P450 2A6.
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Commercial
Trade Name
FDA
EMA
Isopto carpine, Salagen, Vuity (generic drugs available since 2004-11-16, 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)
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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Pilocarpine
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| betoptic pilo | 2006-06-19 | |
| pilocarpine hydrchloride | ANDA | 2023-06-08 |
| salagen | New Drug Application | 2022-02-11 |
| vuity | New Drug Application | 2021-10-28 |
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
158 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 2 | 5 | 3 | 13 | 23 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | 2 | 1 | 4 | 7 |
| Vascular calcification | D061205 | — | 1 | 2 | 3 | — | 6 | ||
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | 1 | 1 | 1 | 1 | — | 4 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | 1 | 2 | 4 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 2 | 1 | 1 | — | 3 |
| Aortic valve disease | D000082862 | — | 1 | — | 1 | — | 2 | ||
| Transcatheter aortic valve replacement | D065467 | — | — | 1 | 1 | — | 2 | ||
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | — | — | 1 | 1 | 2 |
| St elevation myocardial infarction | D000072657 | — | — | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombosis | D013927 | — | 2 | 2 | — | 1 | 5 | ||
| Neoplasms | D009369 | C80 | 2 | — | 1 | — | 1 | 4 | |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | 1 | 1 | — | 1 | 3 |
| Covid-19 | D000086382 | U07.1 | — | 1 | 1 | — | 1 | 3 | |
| Inflammation | D007249 | — | — | 1 | — | 2 | 3 | ||
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 2 | — | 1 | 3 |
| Calciphylaxis | D002115 | — | — | 1 | — | 1 | 2 | ||
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | 1 | 2 | — | — | 2 | |
| Rheumatic heart disease | D012214 | EFO_1001161 | I09.9 | — | — | 1 | — | — | 1 |
| Percutaneous coronary intervention | D062645 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vitamin k deficiency | D014813 | E56.1 | — | 2 | — | — | 3 | 5 | |
| Aortic valve stenosis | D001024 | EFO_0000266 | Q25.1 | — | 1 | — | — | 2 | 3 |
| Vascular stiffness | D059289 | — | 1 | — | — | 2 | 3 | ||
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | — | — | 1 | 2 |
| Folliculitis | D005499 | — | 1 | — | — | — | 1 | ||
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | 1 | |
| Bicuspid aortic valve disease | D000082882 | — | 1 | — | — | — | 1 | ||
| Caroli disease | D016767 | EFO_1001286 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 4 | — | — | — | 6 | 10 | ||
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 3 | — | — | — | — | 3 |
| Dysmenorrhea | D004412 | HP_0100607 | N94.6 | 1 | — | — | — | 1 | 2 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | — | — | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | C61 | 1 | — | — | — | — | 1 | |
| Cerebral hemorrhage | D002543 | 1 | — | — | — | — | 1 | ||
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 3 | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 3 | 3 |
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 3 | 3 | |
| Oxidative stress | D018384 | EFO_1001905 | — | — | — | — | 2 | 2 | |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 2 | 2 |
| Chronic renal insufficiency | D051436 | N18 | — | — | — | — | 2 | 2 | |
| Coronary artery disease | D003324 | I25.1 | — | — | — | — | 2 | 2 | |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Fibrosis | D005355 | — | — | — | — | 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
Alternate
CHRM2
CHRM2
CHRM4
CHRM4
CHRM1
CHRM1
CHRM5
CHRM5
CYP2A6
CYP2A6
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 18,057 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,138 adverse events reported
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