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| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzyme inhibitors | 5823 | None |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Imetelstat is an oligonucleotide telomerase inhibitor. Imetelstat binds to the template region of human telomerase RNA (hTR), resulting in inhibition of telomerase activity.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 6, 2024 | FDA | Geron | |
| March 7, 2025 | EMA | Geron Netherlands B.V. |
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| Source | Code | Description |
|---|---|---|
| ATC | L01XX80 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| FDA EPC | N0000194125 | Oligonucleotide Telomerase Inhibitor |
| FDA MoA | N0000194126 | Oligonucleotide Telomerase Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:233423 | antifibrotic agent |
| CHEBI has role | CHEBI:75835 | anti-anaemic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Low- to intermediate-1 risk myelodysplastic syndrome | indication | 109995007 |
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| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 188MG BASE/VIAL | RYTELO | GERON | N217779 | June 6, 2024 | RX | POWDER | INTRAVENOUS | 9388415 | Sept. 9, 2026 | TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA |
| EQ 188MG BASE/VIAL | RYTELO | GERON | N217779 | June 6, 2024 | RX | POWDER | INTRAVENOUS | 9388416 | Sept. 9, 2026 | TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA |
| EQ 47MG BASE/VIAL | RYTELO | GERON | N217779 | June 6, 2024 | RX | POWDER | INTRAVENOUS | 9388415 | Sept. 9, 2026 | TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA |
| EQ 47MG BASE/VIAL | RYTELO | GERON | N217779 | June 6, 2024 | RX | POWDER | INTRAVENOUS | 9388416 | Sept. 9, 2026 | TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA |
| EQ 188MG BASE/VIAL | RYTELO | GERON | N217779 | June 6, 2024 | RX | POWDER | INTRAVENOUS | 12442000 | March 15, 2033 | TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA |
| EQ 188MG BASE/VIAL | RYTELO | GERON | N217779 | June 6, 2024 | RX | POWDER | INTRAVENOUS | 9375485 | March 15, 2033 | TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA |
| EQ 47MG BASE/VIAL | RYTELO | GERON | N217779 | June 6, 2024 | RX | POWDER | INTRAVENOUS | 12442000 | March 15, 2033 | TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA |
| EQ 47MG BASE/VIAL | RYTELO | GERON | N217779 | June 6, 2024 | RX | POWDER | INTRAVENOUS | 9375485 | March 15, 2033 | TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA |
| EQ 188MG BASE/VIAL | RYTELO | GERON | N217779 | June 6, 2024 | RX | POWDER | INTRAVENOUS | 12171778 | June 16, 2039 | TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA |
| EQ 47MG BASE/VIAL | RYTELO | GERON | N217779 | June 6, 2024 | RX | POWDER | INTRAVENOUS | 12171778 | June 16, 2039 | TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 188MG BASE/VIAL | RYTELO | GERON | N217779 | June 6, 2024 | RX | POWDER | INTRAVENOUS | June 6, 2031 | TREATMENT OF ADULT PATIENTS WITH LOW - TO INTERMEDIATE-1 RISK MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA REQUIRING 4 OR MORE RED BLOOD CELL UNITS OVER 8 WEEKS WHO HAVE NOT RESPONDED TO OR HAVE LOST RESPONSE TO OR ARE INELIGIBLE FOR ERYTHROPOIESIS-STIMULATING AGENTS (ESA) |
| EQ 47MG BASE/VIAL | RYTELO | GERON | N217779 | June 6, 2024 | RX | POWDER | INTRAVENOUS | June 6, 2031 | TREATMENT OF ADULT PATIENTS WITH LOW - TO INTERMEDIATE-1 RISK MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA REQUIRING 4 OR MORE RED BLOOD CELL UNITS OVER 8 WEEKS WHO HAVE NOT RESPONDED TO OR HAVE LOST RESPONSE TO OR ARE INELIGIBLE FOR ERYTHROPOIESIS-STIMULATING AGENTS (ESA) |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Telomerase reverse transcriptase | Enzyme | INHIBITOR | IC50 | 7.25 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| 868169-64-6 | SECONDARY_CAS_RN |
| CHEMBL2107856 | ChEMBL_ID |
| C519562 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB14909 | DRUGBANK_ID |
| DB05036 | DRUGBANK_ID |
| 4043215 | VANDF |
| C2746063 | UMLSCUI |
| CHEBI:752899 | CHEBI |
| CHEMBL2108702 | ChEMBL_ID |
| 9142 | INN_ID |
| 1007380-31-5 | SECONDARY_CAS_RN |
| 72941969 | PUBCHEM_CID |
| 386208 | MMSL |
| 42902 | MMSL |
| d10191 | MMSL |
| 019772 | NDDF |
| 019773 | NDDF |
| 13625 | IUPHAR_LIGAND_ID |
| F60NE4XB53 | UNII |
| 2685236 | RXNORM |
| D09629 | KEGG_DRUG |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| RYTELO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82959-111 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 188 mg | INTRAVENOUS | NDA | 28 sections |
| RYTELO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82959-112 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 47 mg | INTRAVENOUS | NDA | 28 sections |