Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2177 |
| INN | Fulranumab |
| Status | Terminated |
| Drug code(s) | JNJ-42160443, AMG 403 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform) |
| Target(s) | NGF |
| Indications of clinical studies | Pain associated with Osteoarthritis, Arthralgia, Joint Pain, Urologic Diseases, Diabetic Neuropathy, cancer-related pain in terminally ill patients, Neuralgia |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | February 15, 2005 |
| Start of Phase 2 | |
| Start of Phase 3 | March 15, 2015 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Amgen |
| Licensee/Partner | Janssen Research & Development LLC, Takeda |
| Comments about company or candidate | Takeda returned rights in July 2016. Four Phase 3 studies were sponsored by Janssen. March 31, 2016: Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced that it is discontinuing the Phase 3 development program for fulranumab in osteoarthritis pain. This decision was based on strategic portfolio prioritization and was not based on any emerging safety concerns from the Phase 3 clinical studies with fulranumab. Janssen Pharmaceuticals, Inc., an affiliated company, is terminating its licensing agreement with Amgen Inc. for fulranumab and is returning all program rights back to Amgen. NCT00929188 Phase 2 study active not recruiting as of Feb 2014. Phase 1 in Japan? |
| Full address of company | Thousand Oaks, California, United States North America United States of America https://www.amgen.com/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |