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| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5457 | 2019171-69-6 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Pegcetacoplan binds to complement protein C3 and its activation fragment C3b, thereby regulating the cleavage of C3 and the generation of downstream effectors of complement activation. In PNH, extravascular hemolysis (EVH) is facilitated by C3b opsonization while intravascular hemolysis (IVH) is mediated by the downstream membrane attack complex (MAC). Pegcetacoplan acts proximally in the complement cascade controlling both C3b-mediated EVH and terminal complement-mediated IVH.
|
| Dose | Unit | Route |
|---|---|---|
| 0.30 | g | P |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 14, 2021 | FDA | APELLIS PHARMACEUTICALS INC | |
| Dec. 13, 2021 | EMA | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | |
| March 27, 2023 | PMDA | Swedish Orphan Biovitrum Japan Co., Ltd. |
| 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 |
|---|---|---|---|---|---|---|
| Vitritis | 148.19 | 70.66 | 22 | 529 | 1592 | 90626304 |
| Vitreous floaters | 120.52 | 70.66 | 23 | 528 | 7526 | 90620370 |
| Intra-ocular injection complication | 102.21 | 70.66 | 11 | 540 | 51 | 90627845 |
| Retinal vasculitis | 88.52 | 70.66 | 14 | 537 | 1527 | 90626369 |
| Visual impairment | 87.56 | 70.66 | 32 | 519 | 132333 | 90495563 |
| Uveitis | 87.10 | 70.66 | 20 | 531 | 15883 | 90612013 |
| Retinal haemorrhage | 82.25 | 70.66 | 16 | 535 | 5748 | 90622148 |
| Intraocular pressure increased | 78.94 | 70.66 | 16 | 535 | 7077 | 90620819 |
| 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 |
|---|---|---|---|---|---|---|
| Intra-ocular injection complication | 83.93 | 57.72 | 9 | 247 | 41 | 42621038 |
| 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 |
|---|---|---|---|---|---|---|
| Vitritis | 180.24 | 59.00 | 27 | 509 | 2626 | 110586137 |
| Visual impairment | 114.37 | 59.00 | 37 | 499 | 134391 | 110454372 |
| Uveitis | 106.96 | 59.00 | 24 | 512 | 21686 | 110567077 |
| Vitreous floaters | 96.56 | 59.00 | 19 | 517 | 9115 | 110579648 |
| Intra-ocular injection complication | 89.85 | 59.00 | 10 | 526 | 86 | 110588677 |
| Retinal occlusive vasculitis | 89.06 | 59.00 | 11 | 525 | 246 | 110588517 |
| Retinal vasculitis | 87.71 | 59.00 | 14 | 522 | 2035 | 110586728 |
| Retinal haemorrhage | 83.81 | 59.00 | 17 | 519 | 9484 | 110579279 |
| Intraocular pressure increased | 64.38 | 59.00 | 14 | 522 | 10862 | 110577901 |
None
| Source | Code | Description |
|---|---|---|
| ATC | L04AJ03 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Complement inhibitors |
| ATC | S01XA31 | SENSORY ORGANS OPHTHALMOLOGICALS OTHER OPHTHALMOLOGICALS Other ophthalmologicals |
| MeSH PA | D007155 | Immunologic Factors |
| MeSH PA | D007166 | Immunosuppressive Agents |
| MeSH PA | D051056 | Complement Inactivating Agents |
| FDA EPC | N0000175575 | Complement Inhibitor |
| FDA MoA | N0000175974 | Complement Inhibitors |
| CHEBI has role | CHEBI:66981 | ophthalmology drug |
| CHEBI has role | CHEBI:75835 | anti-anaemic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Paroxysmal nocturnal hemoglobinuria | indication | 1963002 | DOID:0060284 |
| Geographic atrophy secondary to age-related macular degeneration | indication | 414875008 | |
| Unresolved serious infection caused by Neisseria meningitidis | contraindication | 23511006 | |
| Unresolved serious infection caused by Haemophilus influenzae | contraindication | 91428005 | |
| Uveitis | contraindication | 128473001 | DOID:13141 |
| Ocular or periocular infection | contraindication | 715266002 |
None
None
None
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 9056076 | Oct. 25, 2026 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN |
| 15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 8168584 | April 7, 2027 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN |
| 15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 8168584 | April 7, 2027 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN AND ALSO ADMINISTERING AN ANTI-VEGF AGENT |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 9169307 | Nov. 18, 2027 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH C3 GLOMERULOPATHY (C3G) OR PRIMARY IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS (IC-MPGN) BY ADMINISTRATION OF COMPLEMENT INHIBITOR PEGCETACOPLAN |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 9169307 | Nov. 18, 2027 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF COMPLEMENT INHIBITOR PEGCETACOPLAN |
| 15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 9169307 | Nov. 18, 2027 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY ADMINISTERING COMPLEMENT INHIBITOR PEGCETACOPLAN |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11661441 | Jan. 13, 2033 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH C3 GLOMERULOPATHY (C3G) OR PRIMARY IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS (IC-MPGN) BY ADMINISTRATION OF PEGCETACOPLAN |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11661441 | Jan. 13, 2033 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN |
| 15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 11661441 | Jan. 13, 2033 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 10875893 | Nov. 15, 2033 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH C3 GLOMERULOPATHY (C3G) OR PRIMARY IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS (IC-MPGN) BY ADMINISTRATION OF PEGCETACOPLAN |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 10875893 | Nov. 15, 2033 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11292815 | Nov. 15, 2033 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH C3 GLOMERULOPATHY (C3G) OR PRIMARY IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS (IC-MPGN) BY ADMINISTRATION OF PEGCETACOPLAN |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11292815 | Nov. 15, 2033 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH C3G OR PRIMARY IC-MPGN BY ADMINISTRATION OF PEGCETACOPLAN SO AS TO REDUCE THE SENSITIVITY OF CELLS TO COMPLEMENT-MEDIATED DAMAGE |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11292815 | Nov. 15, 2033 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11292815 | Nov. 15, 2033 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN SO AS TO REDUCE THE SENSITIVITY OF CELLS TO COMPLEMENT-DEPENDENT DAMAGE |
| 15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 10875893 | Nov. 15, 2033 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN |
| 15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 11292815 | Nov. 15, 2033 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN |
| 15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 12528836 | Oct. 7, 2036 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF 15 MG PEGCETACOPLAN |
| 15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 11903994 | Feb. 22, 2037 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF 15 MG PEGCETACOPLAN EVERY OTHER MONTH |
| 15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 11903994 | Feb. 22, 2037 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF 15 MG PEGCETACOPLAN MONTHLY |
| 15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | 11903994 | Feb. 22, 2037 | TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF 15 MG PEGCETACOPLAN MONTHLY OR EVERY OTHER MONTH |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11040107 | April 9, 2038 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WEIGHING 50 KG OR HIGHER WITH C3 GLOMERULOPATHY OR PRIMARY IMMUNECOMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN TWICE WEEKLY |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11040107 | April 9, 2038 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11040107 | April 9, 2038 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN EVERY THREE DAYS |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11040107 | April 9, 2038 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN TWICE WEEKLY |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11844841 | Dec. 9, 2038 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WEIGHING 50 KG OR HIGHER WITH C3 GLOMERULOPATHY OR PRIMARY IMMUNECOMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN TWICE WEEKLY |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11844841 | Dec. 9, 2038 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11844841 | Dec. 9, 2038 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN EVERY THREE DAYS |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 11844841 | Dec. 9, 2038 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN TWICE WEEKLY |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 12290566 | Dec. 14, 2038 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WEIGHING 50 KG OR HIGHER WITH C3G OR PRIMARY IC-MPGN BY TWICE WEEKLY SUBCUTANEOUS ADMINISTRATION OF A UNIT DOSE OF 1080 MG OFPEGCETACOPLAN IN A COMPOSITION OF CLAIM 1 |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 12290566 | Dec. 14, 2038 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH C3 GLOMERULOPATHY (C3G) OR PRIMARY IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS (IC-MPGN) BY ADMINISTRATION OF A UNIT DOSE OF PEGCETACOPLAN IN A COMPOSITION OF CLAIM 1 |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 12290566 | Dec. 14, 2038 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY SUBCUTANEOUS ADMINISTRATION OF A UNIT DOSE OF 1080 MG OF PEGCETACOPLAN IN A COMPOSITION OF CLAIM 1 |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 12290566 | Dec. 14, 2038 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY TWICE-WEEKLY SUBCUTANEOUS ADMINISTRATION OF A UNIT DOSE OF 1080 MG OF PEGCETACOPLAN IN A COMPOSITION OF CLAIM 1 |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | 12290566 | Dec. 14, 2038 | TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WEIGHING 35 KG TO LESS THAN 50 KG WITH C3G OR PRIMARY IC-MPGN BY TWICE WEEKLY SUBCUTANEOUS ADMINISTRATION OF A UNIT DOSE OF 810 MG OF PEGCETACOPLAN IN A COMPOSITION OF CLAIM 1 |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | Feb. 8, 2026 | INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF STUDY APL2-308 |
| 15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | Feb. 22, 2026 | NEW PRODUCT |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | May 14, 2026 | NEW CHEMICAL ENTITY |
| 15MG/0.1ML (15MG/0.1ML) | SYFOVRE | APELLIS PHARMS | N217171 | Feb. 17, 2023 | RX | SOLUTION | INTRAVITREAL | May 14, 2026 | NEW CHEMICAL ENTITY |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | May 14, 2028 | TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | July 28, 2028 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH C3 GLOMERULOPATHY (C3G) OR PRIMARY IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS (IC-MPGN) TO REDUCE PROTEINURIA |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | July 28, 2032 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH C3 GLOMERULOPATHY (C3G), TO REDUCE PROTEINURIA |
| 1080MG/20ML (54MG/ML) | EMPAVELI | APELLIS PHARMS | N215014 | May 14, 2021 | RX | SOLUTION | SUBCUTANEOUS | July 28, 2032 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH PRIMARY IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS (IC-MPGN), TO REDUCE PROTEINURIA |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Complement C3 | Secreted | INHIBITOR | IC50 | 6.60 | SCIENTIFIC LITERATURE | DRUG LABEL |
| ID | Source |
|---|---|
| TO3JYR3BOU | UNII |
| C5418501 | UMLSCUI |
| CHEBI:757617 | CHEBI |
| CHEMBL4298211 | ChEMBL_ID |
| DB16694 | DRUGBANK_ID |
| 10743 | INN_ID |
| C000716074 | MESH_SUPPLEMENTAL_RECORD_UI |
| 13826 | IUPHAR_LIGAND_ID |
| 1162412004 | SNOMEDCT_US |
| 1162431005 | SNOMEDCT_US |
| 4040509 | VANDF |
| 346711 | MMSL |
| 39544 | MMSL |
| d09749 | MMSL |
| 018732 | NDDF |
| 2557372 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Empaveli | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73606-010 | INJECTION, SOLUTION | 1080 mg | SUBCUTANEOUS | NDA | 33 sections |
| Syfovre | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73606-020 | INJECTION, SOLUTION | 15 mg | INTRAVITREAL | NDA | 29 sections |