Drugs / Tanezumab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Raylumis | — | 2021-11-15 | europa.eu ↗ |
Trials 33 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 215 trials | ||||||
| Phase 2 | NCT04163419 | Apr 2020 → Sep 2022 | schwannomatosis | Massachusetts General Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01146561 | Oct 2010 → Mar 2011 | chronic pancreatitis | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT01087203 | Mar → Nov 2010 | diabetic polyneuropathy | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00999518 | Jan → Nov 2010 | interstitial cystitis | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00994890 | Nov 2009 → Dec 2010 | osteoarthritis, hip, osteoarthritis, knee | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00830180 | Oct 2009 → Feb 2013 | lytic metastatic bone lesion, neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00924664 | Aug 2009 → Nov 2010 | — | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00876187 | Jun 2009 → Jun 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00545129 | Apr 2009 → Dec 2011 | metastatic neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00826514 | Mar 2009 → Jan 2010 | chronic prostatitis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00784693 | Dec 2008 → Jan 2010 | endometriosis | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00601484 | Mar 2008 → Apr 2009 | interstitial cystitis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00584870 | Jul 2007 → Sep 2008 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00399490 | Sep 2006 → Feb 2008 | osteoarthritis, knee | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00394563 | Mar 2006 → Oct 2007 | osteoarthritis, knee | Pfizer | Completed | No outcome recorded |
| Phase 318 trials | ||||||
| Phase 3 | NCT02725411 | May 2016 → Jun 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02709486 | Mar 2016 → Jun 2018 | osteoarthritis, hip, osteoarthritis, knee | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02697773 | Jan 2016 → Dec 2017 | osteoarthritis, hip, osteoarthritis, knee | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02609828 | Oct 2015 → Sep 2020 | bone neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02528253 | Aug 2015 → Oct 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02528188 | Jul 2015 → Oct 2018 | chronic pain syndrome, osteoarthritis, hip, osteoarthritis, knee | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01127893 | Jun → Sep 2010 | osteoarthritis | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT01089725 | Mar → Nov 2010 | osteoarthritis, knee | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00960804 | Feb → Nov 2010 | osteoarthritis | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00985621 | Oct 2009 → Dec 2010 | osteoarthritis | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00864097 | Aug 2009 → Nov 2010 | osteoarthritis | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00863304 | Jun 2009 → Apr 2010 | osteoarthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00863772 | May 2009 → Nov 2010 | osteoarthritis | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00830063 | May 2009 → May 2010 | osteoarthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00809354 | Feb 2009 → Oct 2010 | osteoarthritis | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00809783 | Feb 2009 → Nov 2010 | osteoarthritis | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00744471 | Nov 2008 → Mar 2010 | osteoarthritis, hip | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00733902 | Sep 2008 → Aug 2009 | osteoarthritis | Pfizer | Completed | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01030640 Comparator | Dec 2009 → Sep 2010 | chronic pain syndrome, interstitial cystitis, osteoarthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00788294 Comparator | Nov 2008 → Jun 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT00669409 Comparator | Jun 2008 → Dec 2009 | osteoarthritis, knee | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00568321 Comparator | Dec 2007 → Dec 2008 | postherpetic neuralgia | Pfizer | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT03031938 Background | Nov 2017 → Jun 2020 | osteoarthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02674386 Background | Aug 2016 → Jul 2019 | osteoarthritis | Pfizer | Completed | No outcome recorded |
Press releases naming this drug 9 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-03-25 | Pfizer | Joint FDA Advisory Committee Votes on Application for Tanezumab for the Treatment of Osteoarthritis Pain pfizer.com ↗ |
| 2020-03-02 | Pfizer | U.S. FDA Accepts Regulatory Submission for Tanezumab, a Potential First-in-Class Treatment for Patients with Chronic Pain Due to Moderate-to-Severe Osteoarthritis pfizer.com ↗ |
| 2019-04-18 | Pfizer | Pfizer and Lilly Announce Top-Line Results From Long-Term Phase 3 Study of Tanezumab in Patients With Osteoarthritis pfizer.com ↗ |
| 2019-02-19 | Pfizer | Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain pfizer.com ↗ |
| 2019-01-29 | Pfizer | Pfizer and Lilly Announce Top-Line Results From Second Phase 3 Study of Tanezumab in Osteoarthritis Pain pfizer.com ↗ |
| 2018-10-23 | Pfizer | Complete Results from First Study in Ongoing Phase 3 Program for Tanezumab Demonstrated Significant Improvement in Pain and Function in Osteoarthritis Patients pfizer.com ↗ |
| 2018-07-18 | Pfizer | Pfizer And Lilly Announce Positive Top-Line Results From Phase 3 Trial Of Tanezumab For The Treatment Of Osteoarthritis (OA) Pain pfizer.com ↗ |
| 2017-06-13 | Pfizer | Pfizer and Lilly Receive FDA Fast Track Designation for Tanezumab pfizer.com ↗ |
| 2015-03-23 | Pfizer | Pfizer And Lilly Preparing To Resume Phase 3 Chronic Pain Program For Tanezumab pfizer.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tanezumab | “This prospective cohort study (ClinicalTrials.gov identifier: NCT02674386) evaluated the postoperative outcomes of patients who had undergone total joint replacement (TJR)...” PMID 34043229 ↗ May 202134“This study was designed to evaluate the long-term safety and effectiveness of repeated doses of the humanized anti-nerve growth factor antibody, tanezumab, during open-label...” PMID 21251985 ↗ Jan 2011 “IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study” NCT03031938 ↗ “Tanezumab, a nerve growth factor monoclonal antibody, has demonstrated efficacy in chronic pain.” PMID 25919474 ↗ Sep 2015 “PF-04383119 (tanezumab)” NCT00669409 ↗ |
| Known as | PF-04383119 | “Drug: RN624 (PF-04383119)” NCT00394563 ↗ |
| Known as | PF-4383119 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108567 ↗ |
| Known as | RN624 | “PF-04383119 (RN624)” NCT00584870 ↗ |
| Action | Inhibit | “binds and inhibits nerve growth factor” PMID 20942668 ↗ Sep 2010 |
| Modality | Monoclonal antibody | “a humanized monoclonal antibody” PMID 20942668 ↗ Sep 2010 |
| Route | Intravenous | “Single intravenous injection of 10 mg tanezumab or placebo” PMID 25919474 ↗ Sep 2015 |
| Target | NGF | “Nerve growth factor is involved in pain signaling. Tanezumab, a nerve growth factor monoclonal antibody, has demonstrated efficacy in chronic pain.” PMID 25919474 ↗ Sep 2015 |