oprelvekin
Trade name: Neumega
Recombinant proteinapprovedOrphan Drug FDA
Approved
Nov 25, 1997
Interleukin 11 is a protein that in humans is encoded by the IL11 gene. — Wikipedia
Clinical trial activity
18 trials · 23 clinical orgs · 1 marketing orgs
Phase 1
3
Phase 2
13
Phase 3
4
Phase 4
1
Earliest trial started Aug 1, 2000 (NCT00004157)
Timeline
1990s
- Dec 17, 1996
Orphan Drug Designation
- Nov 25, 1997
American Home Products — Earliest FDA Approval
- Nov 25, 1997
American Home Products — NDA Secondary Org
- Nov 25, 1997
American Home Products — NDA Organization
2010s
- Jan 1, 2015
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Studied for
- Breast Neoplasms · Phase 2
- Colitis, Ulcerative · Phase 1
- Colorectal Neoplasms · Phase 2
- Crohn Disease · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Gestational Trophoblastic Disease · Phase 2
- Hematologic Diseases · Phase 2/Phase 3
- Hemophilia A · Phase 2
- Inflammatory Bowel Diseases · Phase 2
- Kidney Neoplasms · Phase 2
- Leukemia · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 1/Phase 2
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 2
- Lymphoma · Phase 2
- Lymphoma, B-Cell, Marginal Zone · Phase 1/Phase 2
- Lymphoma, Follicular · Phase 1/Phase 2
- Nasopharyngeal Carcinoma · Phase 3
- Neoplasms · Phase 1
- Neuroblastoma · Phase 2
- Ovarian Neoplasms · Phase 2
- Sarcoma · Phase 2
- Testicular Neoplasms · Phase 2
- Thrombocytopenia · Phase 2/Phase 3
- von Willebrand Diseases · Phase 2
- Waldenstrom Macroglobulinemia · Phase 1/Phase 2
Mechanism of action
IL11RA agonist
complex with beta but only associcates on ligand binding so excluded
- Interleukin-11Supplementation
IL11 supplementation
Approval history
- approvedNov 25, 1997
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaInterleukin 11 ↗
- NCATSHM5641GA6F ↗
- ChEMBLCHEMBL1201573 ↗
- WikipediaOprelvekin ↗
Also known as
- adipogenesis inhibitory factor
- agif
- il11
- il-11
- il-11
- il-11
- il-11
- interleukin 11
- interleukin-11
- interleukin-11 precursor
- neumega
- neumega
- neumega
- neumega
- nl201
- oprelvekin
- oprelvekin
- oprelvekin
- oprelvekin
- oprelvekin
- oprelvekin
- oprelvekin
- oprelvekin
- oprelvekin (genetical recombination)
- rhil-11
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07185893 | N/A | Sep 30, 2025 | Hebei University |
| NCT06759636 | Phase 3 | Jan 21, 2025 | Nanjing Medical University |
| NCT04659629 | Phase 1 | Dec 31, 2020 | Neoleukin, Neoleukin Therapeutics, Inc. |
| NCT03823079 | Phase 2 | Feb 1, 2019 | Fudan University |
| NCT03720340 | Phase 3 | Nov 11, 2018 | Chinese Academy of Medical Sciences |
| NCT01663441 | Phase 3 | Mar 1, 2015 | Beijing Northland Biotech. Co., Ltd. |
| NCT02241031 | Phase 2/Phase 3 (Phase 3) | Sep 1, 2014 | Guangzhou Medical University, Huazhong University of Science and Technology, Peking University, Shantou University, Southern Medical University, Sun Yat-Sen University |
| NCT02314273 | Phase 4 | Sep 1, 2011 | Jiao Tong University, Xiamen Amoytop Biotech Co., Ltd. |
| NCT00994929 | Phase 2 | Jan 1, 2010 | University of Pittsburgh |
| NCT00886743 | Phase 2 | Sep 1, 2009 | Pfizer |
| NCT00524225 | Phase 2 | Feb 1, 2008 | University of North Carolina at Chapel Hill, University of Pittsburgh, Wyeth |
| NCT00524342 | Phase 2 | Jan 1, 2008 | University of North Carolina at Chapel Hill, University of Pittsburgh, Wyeth |
| NCT00493181 | Phase 2 | Oct 1, 2005 | University of Texas at Houston, Wyeth |
| NCT00151125 | Phase 2 | Jul 1, 2004 | University of North Carolina at Chapel Hill, University of Pittsburgh, Wyeth |
| NCT00038922 | Phase 1 | Jun 5, 2002 | Pfizer, Wyeth |
| NCT00040521 | Phase 2 | Apr 1, 2002 | Pfizer, Wyeth |
| NCT00012298 | Phase 1/Phase 2 (Phase 2) | Apr 1, 2001 | Mayo Clinic, National Cancer Institute (NCI) |
| NCT00004157 | Phase 2 | Aug 1, 2000 | National Cancer Institute (NCI), University of Washington |
Showing 18 of 18 trials
Page 1 / 1
Organizations
Research & Development (23)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Wyeth | For profit | 6 | 0 | 2 | 2002 |
| University of Pittsburgh | Academic/Hospital | 4 | 4 | 1 | 2004 |
| Pfizer | For profit | 3 | 3 | 2 | 2002 |
| University of North Carolina at Chapel Hill | Academic/Hospital | 3 | 0 | 1 | 2004 |
| National Cancer Institute (NCI) | Government | 2 | 1 | 1 | 2000 |
| Beijing Northland Biotech. Co., Ltd. | For profit | 1 | 1 | 1 | 2015 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Fudan University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Guangzhou Medical University | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Hebei University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Huazhong University of Science and Technology | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Jiao Tong University | Academic/Hospital | 1 | 1 | 1 | 2011 |
| Mayo Clinic | Academic/Hospital | 1 | 0 | 1 | 2001 |
| Nanjing Medical University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Neoleukin | For profit | 1 | 0 | 1 | 2020 |
| Neoleukin Therapeutics, Inc. | For profit | 1 | 1 | 1 | 2020 |
| Peking University | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Shantou University | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Southern Medical University | Academic/Hospital | 1 | 1 | 1 | 2014 |
| Sun Yat-Sen University | Academic/Hospital | 1 | 0 | 1 | 2014 |
23 organizations
Page 1 / 2
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| American Home Products | For profit | NDA2 | Nov 25, 1997 |
| American Home Products | For profit | NDA | Nov 25, 1997 |