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sofpironium bromide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5428 | 1628106-94-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Sofpironium bromide gel is a topical anticholinergic agent developed for the treatment of hyperhidrosis. The drug is designed to reduce sweating by inhibiting M3 muscarinic receptors in eccrine glands at the application site.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 0.584 | Moderate | 0.70 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 11.940 | Moderate | 0.70 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 1.406 | 10^-6 cm/s | Moderate | 0.70 |
| dh-clint | Dog hepatocyte intrinsic clearance | 8.730 | uL/min/10^6 cells | Moderate | 0.70 |
| dppb | Dog plasma protein binding (% unbound) | 49.940 | % | Moderate | 0.70 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 33.750 | % | Moderate | 0.70 |
| herg | hERG pIC50 | 4.647 | pIC50 | Moderate | 0.70 |
| hh-clint | Human hepatocyte intrinsic clearance | 5.768 | uL/min/10^6 cells | Moderate | 0.70 |
| hlm-clint | Human liver microsomal intrinsic clearance | 66.222 | uL/min/mg protein | Moderate | 0.70 |
| hppb | Human plasma protein binding (% unbound) | 39.670 | % | Moderate | 0.70 |
| kinase-safety-class | ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CG,PRKDC,TEK,TGFBR1 | 23 | |||
| kinase-selectivity-class | AXL,GRK2,PDK4 | 3 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 2.780 | Moderate | 0.70 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 5.070 | Moderate | 0.70 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 47.206 | Moderate | 0.70 | |
| mppb | Mouse plasma protein binding (% unbound) | 31.120 | Moderate | 0.70 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 9.099 | Moderate | 0.70 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 59.270 | % | Moderate | 0.70 |
| rat-kpuu-brain | Rat brain Kpuu | 0.036 | % | Moderate | 0.70 |
| rh-clint | Rat hepatocyte intrinsic clearance | 64.863 | uL/min/10^6 cells | Moderate | 0.70 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 85.250 | % | Moderate | 0.70 |
| rppb | Rat plasma protein binding (% unbound) | 38.580 | % | Moderate | 0.70 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 870.964 | uM | Moderate | 0.70 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 25, 2020 | PMDA | Kaken Pharmaceutical |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | D11AA02 | DERMATOLOGICALS OTHER DERMATOLOGICAL PREPARATIONS OTHER DERMATOLOGICAL PREPARATIONS Antihidrotics |
| FDA MoA | N0000175370 | Cholinergic Antagonists |
| FDA EPC | N0000175574 | Anticholinergic |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D018678 | Cholinergic Agents |
| MeSH PA | D018680 | Cholinergic Antagonists |
Related Drugs by ATC class:
D11AA Antihidrotics 1 drug
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hyperhidrosis | indication | 312230002 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 8628759 | Nov. 13, 2026 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 10383846 | March 14, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 9220707 | March 14, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 9492429 | March 14, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 9895350 | March 14, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 10947192 | May 22, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 10952990 | May 22, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 10959983 | May 22, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 10961191 | May 22, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 11026919 | May 22, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 11034652 | May 22, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 11052067 | May 22, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 11084788 | May 22, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 12156865 | May 22, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 12357609 | May 22, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 12398102 | May 22, 2034 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | 11123325 | July 20, 2037 | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | SOFDRA | BOTANIX SB | N217347 | June 18, 2024 | RX | GEL, METERED | TOPICAL | June 20, 2029 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Muscarinic acetylcholine receptor M3 | GPCR | INHIBITOR | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| D10989 | KEGG_DRUG |
| 7B2Y1932XU | UNII |
| 1628251-49-9 | SECONDARY_CAS_RN |
| C4726762 | UMLSCUI |
| CHEBI:755737 | CHEBI |
| CHEMBL3707223 | ChEMBL_ID |
| 86301316 | PUBCHEM_CID |
| CHEMBL3707224 | ChEMBL_ID |
| 10398 | INN_ID |
| C000731748 | MESH_SUPPLEMENTAL_RECORD_UI |
| 4044031 | VANDF |
| 42920 | MMSL |
| 019792 | NDDF |
| 019793 | NDDF |
| 13426 | IUPHAR_LIGAND_ID |
| 2689321 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Sofdra | HUMAN PRESCRIPTION DRUG LABEL | 1 | 83723-010 | GEL | 87 mg | TOPICAL | NDA | 31 sections |