Drugs / rhBMP-2
rhBMP-2
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Inductos | — | 2002-09-09 | europa.eu ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05719181 | Dec 2021 → Mar 2023 | diabetes mellitus, hematologic disorder, hypertensive disorder | University of Baghdad | Unknown | No outcome recorded |
| Phase 1 | NCT00161629 | Sep 2005 → Jan 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00243295 | Nov 2003 → Mar 2005 | osteoarthritis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07858643 | Apr 2026 → Oct 2027 expected | lumbar disk degenerative disorder | Locate Bio Ltd | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT00752557 | Dec 2008 → Apr 2015 | osteoporosis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00384358 | Dec 2006 → Jun 2010 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00387686 | Nov 2006 → Jul 2009 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT01541345 | Feb 2011 → Apr 2014 | tooth agenesis | University of Zurich | Completed | No outcome recorded |
| Phase 3 | NCT01634308 | Jun 2010 → Jun 2012 | — | Daewoong Pharmaceutical Co. LTD. | Completed | Met primary |
| Phase 42 trials · 1 missed | ||||||
| Phase 4 | NCT04234971 | Jun 2021 → Jan 2028 expected | cleft lip/palate | The University of Texas Health Science Center, Houston | Recruiting | No outcome recorded |
| Phase 4 | NCT00161616 | Sep 2003 → Jul 2008 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | Missed primary |
| Phase not applicable4 trials | ||||||
| — | NCT07696299 | Dec 2026 → Mar 2028 expected | — | University of Baghdad | Not yet recruiting | No outcome recorded |
| — | NCT07240493 | Dec 2024 → Dec 2025 | external pathological resorption | Aya Adil Saeed | Completed | No outcome recorded |
| — | NCT05911477 | Jul → Dec 2023 | osteoporosis | Xijing Hospital | Unknown | No outcome recorded |
| — | NCT05717478 | Nov 2022 → Sep 2024 | periodontal disorder | Universidad Complutense de Madrid | Unknown | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1/2 | NCT04140006 Comparator | Jul 2019 → Jul 2020 | — | University of Baghdad | Unknown | No outcome recorded |
| Phase 4 | NCT03527966 Comparator | Jul 2017 → Jul 2018 | vertebral column disorder | Virtua Health, Inc. | Terminated | No outcome recorded |
| — | NCT04372420 Comparator | Dec 2017 → Sep 2019 | periodontitis | SVS Institute of Dental Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2010-10-01 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong received the clinical permission for ‘NOVOSIS’, an innovative medical device daewoong.co.kr ↗
Daewoong Pharmaceutical Co., Ltd. (CEO Lee, Jong Wook) obtains an authorization for ‘NOVOSIS’, a complex between bone graft materials and BMP-2(a protein of osteoplastic promotion) as new medical device. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-04-04 | PT Kalbe Farma Tbk | KALBE LAUNCH THE FIRST NOVOSIS, AN INNOVATIVE PRODUCT OF BONGRAFT COMBINED WITH GROWTH FACTOR, IN INDONESIA co.id ↗ |
| 2013-04-16 | Daewoong Pharmaceutical Co. LTD. | Daewoong Pharm launched ‘new concept bio fusion medical instrument, ‘NOVOSIS-DENT’. daewoong.co.kr ↗ |
| 2011-07-04 | Daewoong Pharmaceutical Co. LTD. | New-concept medical equipment ‘Novosis’clinical test started in Orthopedics in addition to dentistry daewoong.co.kr ↗ |
| 2010-10-01 | Daewoong Pharmaceutical Co. LTD. | Daewoong received the clinical permission for ‘NOVOSIS’, an innovative medical device daewoong.co.kr ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rhBMP-2 | “A PHASE 2, MULTICENTER, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, DOSE-FINDING AND SAFETY STUDY OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RHBMP-2)/CALCIUM...” NCT00752557 ↗17“For the treatment group, 10cc of crushed DBM will be mixed with the micro-sized sponge of rh-BMP-2 (Infuse Bone Graft, Medronic, Minneapolis, MN).” NCT04234971 ↗ “low-dose Escherichia coli-derived recombinant human bone morphogenetic protein 2 (rhBMP-2) soaked with hydroxyapatite granules (BMP-2/H)” PMID 26185033 ↗ Jul 2015 “Recombinant Human Bone Morphogenetic Protein-2(rhBMP-2) in Patients With Osteoporosis After Lumbar Fusion” NCT05911477 ↗ “InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage” NCT00161616 ↗ “CowellBMP, recombinant human bone morphogenic protein type 2, rhBMP2” NCT04140006 ↗ “LDGraft (b-TCP / rhBMP-2) bone graft substitute” NCT07858643 ↗ |
| Known as | bongros | “Novosis(bongros/BMP-2)” NCT01634308 ↗ |
| Known as | CowellBMP | “CowellBMP, recombinant human bone morphogenic protein type 2, rhBMP2” NCT04140006 ↗ |
| Known as | InductOs | “InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage” NCT00161616 ↗ |
| Known as | Infuse Bone Graft | “For the treatment group, 10cc of crushed DBM will be mixed with the micro-sized sponge of rh-BMP-2 (Infuse Bone Graft, Medronic, Minneapolis, MN).” NCT04234971 ↗ |
| Known as | Novosis | “Novosis(bongros/BMP-2)” NCT01634308 ↗ |
| Known as | Recombinant Human Bone Morphogenetic Protein-2 | “A PHASE 2, MULTICENTER, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, DOSE-FINDING AND SAFETY STUDY OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RHBMP-2)/CALCIUM...” NCT00752557 ↗3“A Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study Of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) In Closed...” NCT00387686 ↗ “Recombinant Human Bone Morphogenetic Protein-2(rhBMP-2) in Patients With Osteoporosis After Lumbar Fusion” NCT05911477 ↗ “Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge .” NCT05719181 ↗ |
| Known as | Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) | “Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)” NCT07696299 ↗ |
| Known as | rhBMP-2/CPM | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00384358 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant Human Bone Morphogenetic Protein-2” NCT00161629 ↗ |
| Route | Other | “implanted once at the time of definitive fracture coverage” NCT00161616 ↗ |