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| Stem definition | Drug id | CAS RN |
|---|---|---|
| corticotropin-releasing factor (CRF) receptor antagonists | 5844 | None |
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 13, 2024 | FDA | Neurocrine Biosciences |
None
None
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None
| Source | Code | Description |
|---|---|---|
| FDA EPC | N0000194151 | Corticotropin-releasing Factor Type 1 Receptor Antagonist |
| FDA MoA | N0000194152 | Corticotropin-releasing Factor Type 1 Receptor Antagonists |
| CHEBI has role | CHEBI:35469 | antidepressant |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Congenital adrenal hyperplasia | indication | 237751000 |
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| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 100MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | 10905690 | Jan. 21, 2035 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 100MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | 11311544 | Jan. 21, 2035 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 100MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | 11730739 | Jan. 21, 2035 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 25MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | 10905690 | Jan. 21, 2035 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 25MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | 11311544 | Jan. 21, 2035 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 25MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | 11730739 | Jan. 21, 2035 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 50MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | 10905690 | Jan. 21, 2035 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 50MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | 11311544 | Jan. 21, 2035 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 50MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | 11730739 | Jan. 21, 2035 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 50MG/ML | CRENESSITY | NEUROCRINE | N218820 | Dec. 13, 2024 | RX | SOLUTION | ORAL | 10905690 | Jan. 21, 2035 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 50MG/ML | CRENESSITY | NEUROCRINE | N218820 | Dec. 13, 2024 | RX | SOLUTION | ORAL | 11311544 | Jan. 21, 2035 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 50MG/ML | CRENESSITY | NEUROCRINE | N218820 | Dec. 13, 2024 | RX | SOLUTION | ORAL | 11730739 | Jan. 21, 2035 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 100MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | 12128033 | June 9, 2041 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 25MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | 12128033 | June 9, 2041 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 50MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | 12128033 | June 9, 2041 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 50MG/ML | CRENESSITY | NEUROCRINE | N218820 | Dec. 13, 2024 | RX | SOLUTION | ORAL | 12128033 | June 9, 2041 | ADJUNCTIVE TREATMENT OF CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 100MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | Dec. 13, 2029 | NEW CHEMICAL ENTITY |
| 25MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | Dec. 13, 2029 | NEW CHEMICAL ENTITY |
| 50MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | Dec. 13, 2029 | NEW CHEMICAL ENTITY |
| 50MG/ML | CRENESSITY | NEUROCRINE | N218820 | Dec. 13, 2024 | RX | SOLUTION | ORAL | Dec. 13, 2029 | NEW CHEMICAL ENTITY |
| 100MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | Dec. 13, 2031 | ADJUNCTIVE TREATMENT TO GLUCOCORTICOID REPLACEMENT TO CONTROL ANDROGENS IN ADULTS AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER WITH CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 25MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | Dec. 13, 2031 | ADJUNCTIVE TREATMENT TO GLUCOCORTICOID REPLACEMENT TO CONTROL ANDROGENS IN ADULTS AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER WITH CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 50MG | CRENESSITY | NEUROCRINE | N218808 | Dec. 13, 2024 | RX | CAPSULE | ORAL | Dec. 13, 2031 | ADJUNCTIVE TREATMENT TO GLUCOCORTICOID REPLACEMENT TO CONTROL ANDROGENS IN ADULTS AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER WITH CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| 50MG/ML | CRENESSITY | NEUROCRINE | N218820 | Dec. 13, 2024 | RX | SOLUTION | ORAL | Dec. 13, 2031 | ADJUNCTIVE TREATMENT TO GLUCOCORTICOID REPLACEMENT TO CONTROL ANDROGENS IN ADULTS AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER WITH CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH) |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Corticotropin-releasing factor receptor 1 | GPCR | ANTAGONIST | IC50 | 8.40 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| 752253-39-7 | SECONDARY_CAS_RN |
| CHEMBL291657 | ChEMBL_ID |
| C000723083 | MESH_SUPPLEMENTAL_RECORD_UI |
| 4043642 | VANDF |
| C5420921 | UMLSCUI |
| CHEBI:34969 | CHEBI |
| 10958 | INN_ID |
| 5282340 | PUBCHEM_CID |
| 3533 | IUPHAR_LIGAND_ID |
| MFT24BX55I | UNII |
| 2701386 | RXNORM |
| C502407 | MESH_SUPPLEMENTAL_RECORD_UI |
| D12366 | KEGG_DRUG |
| 391363 | MMSL |
| 43591 | MMSL |
| d10238 | MMSL |
| 019945 | NDDF |
| MFT24BX55I | INXIGHT DRUGS |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Crenessity | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70370-5025 | CAPSULE | 25 mg | ORAL | NDA | 29 sections |
| Crenessity | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70370-5050 | CAPSULE | 50 mg | ORAL | NDA | 29 sections |
| Crenessity | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70370-5100 | CAPSULE | 100 mg | ORAL | NDA | 29 sections |
| Crenessity | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70370-5250 | SOLUTION | 50 mg | ORAL | NDA | 29 sections |