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acoltremon 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5773 | 68489-09-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Acoltremon, the active substance in TRYPTYR, is an agonist of transient receptor potential melastatin 8 (TRPM8) thermoreceptors. TRPM8 thermoreceptor stimulation has been shown to activate trigeminal nerve signaling leading to increased basal tear production. The exact mechanism of action for TRYPTYR in dry eye disease is unknown.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 28, 2025 | FDA | ALCON LABS INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Eye irritation | 5541.64 | 194.49 | 935 | 1996 | 33043 | 90592473 |
| Eye pain | 1387.07 | 194.49 | 312 | 2619 | 43856 | 90581660 |
| Ocular hyperaemia | 638.24 | 194.49 | 159 | 2772 | 33639 | 90591877 |
| Drug ineffective | 325.09 | 194.49 | 299 | 2632 | 1383999 | 89241517 |
| Vision blurred | 322.10 | 194.49 | 124 | 2807 | 110169 | 90515347 |
| Ocular discomfort | 315.74 | 194.49 | 66 | 2865 | 6304 | 90619212 |
| Lacrimation increased | 278.64 | 194.49 | 79 | 2852 | 26983 | 90598533 |
| Eye pruritus | 195.18 | 194.49 | 61 | 2870 | 28966 | 90596550 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Eye irritation | 828.01 | 207.18 | 130 | 246 | 11188 | 42609771 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Eye irritation | 4802.33 | 242.93 | 782 | 1670 | 32670 | 110554177 |
| Eye pain | 1107.26 | 242.93 | 248 | 2204 | 49851 | 110536996 |
| Ocular hyperaemia | 565.79 | 242.93 | 138 | 2314 | 39148 | 110547699 |
| Drug ineffective | 366.12 | 242.93 | 283 | 2169 | 1520257 | 109066590 |
| Vision blurred | 274.68 | 242.93 | 104 | 2348 | 128918 | 110457929 |
| Lacrimation increased | 264.77 | 242.93 | 72 | 2380 | 30878 | 110555969 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| FDA EPC | N0000194172 | TRPM8 Thermoreceptor Agonist |
| FDA MoA | N0000194173 | TRPM8 Thermoreceptor Agonists |
| CHEBI has role | CHEBI:66981 | ophthalmology drug |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Dry eye disease | indication | 46152009 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.003% | TRYPTYR | ALCON LABS INC | N217370 | May 28, 2025 | RX | SOLUTION/DROPS | OPHTHALMIC | 10028920 | Sept. 8, 2031 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
| 0.003% | TRYPTYR | ALCON LABS INC | N217370 | May 28, 2025 | RX | SOLUTION/DROPS | OPHTHALMIC | 9095609 | Sept. 8, 2031 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
| 0.003% | TRYPTYR | ALCON LABS INC | N217370 | May 28, 2025 | RX | SOLUTION/DROPS | OPHTHALMIC | 9433679 | Sept. 8, 2031 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
| 0.003% | TRYPTYR | ALCON LABS INC | N217370 | May 28, 2025 | RX | SOLUTION/DROPS | OPHTHALMIC | 11850221 | Dec. 16, 2042 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
| 0.003% | TRYPTYR | ALCON LABS INC | N217370 | May 28, 2025 | RX | SOLUTION/DROPS | OPHTHALMIC | 12336971 | Dec. 16, 2042 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.003% | TRYPTYR | ALCON LABS INC | N217370 | May 28, 2025 | RX | SOLUTION/DROPS | OPHTHALMIC | May 28, 2030 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Transient receptor potential cation channel subfamily M member 8 | Ion channel | AGONIST | EC50 | 6 | DRUG LABEL | ||||
| Transient receptor potential cation channel subfamily M member 8 | Ion channel | ACTIVATOR | EC50 | 4.90 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| KXS | PDB_CHEM_ID |
| CHEMBL2441929 | ChEMBL_ID |
| C000731855 | MESH_SUPPLEMENTAL_RECORD_UI |
| 4343 | IUPHAR_LIGAND_ID |
| 4044061 | VANDF |
| C5708849 | UMLSCUI |
| CHEBI:755043 | CHEBI |
| 12127 | INN_ID |
| D13125 | KEGG_DRUG |
| 11266244 | PUBCHEM_CID |
| 395066 | MMSL |
| 44103 | MMSL |
| 020134 | NDDF |
| 1L7BVT4Z4Z | UNII |
| 2716801 | RXNORM |
| 1L7BVT4Z4Z | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| TRYPTYR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0065-8595 | SOLUTION | 0.03 mg | TOPICAL | NDA | 24 sections |