Drugs / Tanezumab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Raylumis | osteoarthritis | 2021-11-15 | “a negative opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use on the tanezumab Marketing Authorization Application in OA” lilly.com ↗ “a negative opinion adopted by the EMA’s CHMP on the tanezumab marketing authorization application in OA” pfizer.com ↗ |
| Filed | EU (EMA) | — | osteoarthritis | 2020-04-28 | “the European Medicines Agency validated for review a Marketing Authorisation Application for tanezumab 2.5 mg administered subcutaneously” pfizer.com ↗ |
| Filed | US (FDA) | — | osteoarthritis | 2020-03-02 | “the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for tanezumab” lilly.com ↗ |
| Rejected (CRL) | US (FDA) | — | osteoarthritis | — | “receipt of a Complete Response Letter (CRL) from the FDA for the tanezumab application in osteoarthritis (OA)” pfizer.com ↗ “receipt of a Complete Response Letter from the FDA for the tanezumab application in osteoarthritis (OA)” lilly.com ↗ |
Trials 31
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 213 trials · 3 met primary · 3 missed | ||||||
| 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 | Met primary |
| 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 | Met primary |
| Phase 2 | NCT00545129 | Apr 2009 → Dec 2011 | metastatic neoplasm | Pfizer | Completed | Missed primary |
| Phase 2 | NCT00826514 | Mar 2009 → Jan 2010 | chronic prostatitis | Pfizer | Completed | Missed primary |
| Phase 2 | NCT00784693 | Dec 2008 → Jan 2010 | endometriosis | Pfizer | Terminated | Missed primary Stop: Enrollment |
| 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 | Met primary |
| Phase 318 trials · 8 met primary · 1 missed | ||||||
| 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 | Mixed |
| Phase 3 | NCT02697773 | Jan 2016 → Dec 2017 | osteoarthritis, hip, osteoarthritis, knee | Pfizer | Completed | Met primary |
| Phase 3 | NCT02609828 | Oct 2015 → Sep 2020 | bone neoplasm | Pfizer | Completed | Met primary |
| 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 | Mixed |
| 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 | Met primary |
| Phase 3 | NCT00864097 | Aug 2009 → Nov 2010 | osteoarthritis | Pfizer | Terminated | Met primary |
| Phase 3 | NCT00863304 | Jun 2009 → Apr 2010 | osteoarthritis | Pfizer | Completed | Met primary |
| Phase 3 | NCT00863772 | May 2009 → Nov 2010 | osteoarthritis | Pfizer | Terminated | Missed primary |
| Phase 3 | NCT00830063 | May 2009 → May 2010 | osteoarthritis | Pfizer | Completed | Met primary |
| Phase 3 | NCT00809354 | Feb 2009 → Oct 2010 | osteoarthritis | Pfizer | Terminated | Mixed |
| Phase 3 | NCT00809783 | Feb 2009 → Nov 2010 | osteoarthritis | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00744471 | Nov 2008 → Mar 2010 | osteoarthritis, hip | Pfizer | Completed | Met primary |
| Phase 3 | NCT00733902 | Sep 2008 → Aug 2009 | osteoarthritis | Pfizer | Completed | Met primary |
| Comparator or background therapy5 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 2 | NCT00568321 Comparator | Dec 2007 → Dec 2008 | postherpetic neuralgia | Pfizer | Completed | No outcome recorded |
| 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 |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2021-08-03 | Eli Lilly and Company | Results Lilly Delivers Strong Second-Quarter 2021 Financial Results, Updates 2021 Financial Guidance lilly.com ↗
The company and Pfizer Inc. announced top-line results of a Phase 3 study evaluating subcutaneous administration of tanezumab in adults with moderate to severe cancer pain due to bone metastases or multiple myeloma. |
| 2021-03-25 | Pfizer | Regulatory Joint FDA Advisory Committee Votes on Application for Tanezumab for the Treatment of Osteoarthritis Pain pfizer.com ↗
There was a single voting question focused on whether the proposed risk evaluation and mitigation strategy (REMS) for tanezumab will ensure its benefits outweigh its risks, and the Committee voted 1 in favor and 19 against. |
| 2021-03-25 | Eli Lilly and Company | Regulatory Joint FDA Advisory Committee Votes on Application for Tanezumab for the Treatment of Osteoarthritis Pain lilly.com ↗
There was a single voting question focused on whether the proposed risk evaluation and mitigation strategy (REMS) for tanezumab will ensure its benefits outweigh its risks, and the Committee voted 1 in favor and 19 against. |
| 2020-03-02 | Pfizer | Regulatory 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 ↗ |
| 2020-03-02 | Eli Lilly and Company | Regulatory 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 lilly.com ↗ |
| 2019-04-18 | Pfizer | Results Pfizer and Lilly Announce Top-Line Results From Long-Term Phase 3 Study of Tanezumab in Patients With Osteoarthritis pfizer.com ↗
In the safety analysis, there was a higher rate of joint safety events in the tanezumab arms compared to NSAIDs at 80 weeks; the difference was statistically significant. |
| 2019-04-18 | Eli Lilly and Company | Results Pfizer and Lilly Announce Top-Line Results From Long-Term Phase 3 Study of Tanezumab in Patients With Osteoarthritis lilly.com ↗
Patients who received tanezumab 2.5 mg did not experience a statistically significant improvement in pain, physical function or patients’ overall assessment of their OA at 16 weeks compared to NSAIDs. |
| 2019-02-19 | Pfizer | Results Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain pfizer.com ↗
In the study, treatment with tanezumab 10 mg met the primary endpoint, demonstrating a statistically significant improvement in pain at 16 weeks compared to placebo. |
| 2019-02-19 | Eli Lilly and Company | Results Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain lilly.com ↗
In the study, treatment with tanezumab 10 mg met the primary endpoint, demonstrating a statistically significant improvement in pain at 16 weeks compared to placebo. |
| 2019-01-29 | Pfizer | Results Pfizer and Lilly Announce Top-Line Results From Second Phase 3 Study of Tanezumab in Osteoarthritis Pain pfizer.com ↗
Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced positive top-line results from a Phase 3 study evaluating tanezumab 2.5 mg or 5 mg in patients with moderate-to-severe osteoarthritis (OA) pain. |
| 2019-01-29 | Eli Lilly and Company | Results Pfizer and Lilly Announce Top-Line Results From Second Phase 3 Study of Tanezumab in Osteoarthritis Pain lilly.com ↗
The tanezumab 5 mg treatment arm met all three co-primary endpoints at 24 weeks, demonstrating a statistically significant improvement in pain, physical function and the patients’ overall assessment of their OA compared to those receiving placebo. |
| 2018-10-23 | Pfizer | Results Complete Results from First Study in Ongoing Phase 3 Program for Tanezumab Demonstrated Significant Improvement in Pain and Function in Osteoarthritis Patients pfizer.com ↗ |
| 2018-10-23 | Eli Lilly and Company | Results Complete Results from First Study in Ongoing Phase 3 Program for Tanezumab Demonstrated Significant Improvement in Pain and Function in Osteoarthritis Patients lilly.com ↗
The study met all three co-primary efficacy endpoints, demonstrating that among patients with moderate-to-severe OA pain of the knee or hip, both dosing regimens of tanezumab were associated with a statistically significant improvement in pain, physical function and patient’s global assessment of their OA, compared to placebo. |
| 2018-07-18 | Pfizer | Results Pfizer And Lilly Announce Positive Top-Line Results From Phase 3 Trial Of Tanezumab For The Treatment Of Osteoarthritis (OA) Pain pfizer.com ↗
The study demonstrated that patients who received two doses of tanezumab separated by eight weeks experienced a statistically significant improvement in pain, physical function and the patients’ overall assessment of their OA, compared to those receiving placebo. |
| 2017-06-13 | Pfizer | Regulatory Pfizer and Lilly Receive FDA Fast Track Designation for Tanezumab pfizer.com ↗
It is the first NGF inhibitor to receive Fast Track designation, a process designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs. |
| 2017-06-13 | Eli Lilly and Company | Regulatory Pfizer and Lilly Receive FDA Fast Track Designation for Tanezumab lilly.com ↗
It is the first NGF inhibitor to receive Fast Track designation, a process designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs. |
| 2015-03-23 | Pfizer | Regulatory Pfizer And Lilly Preparing To Resume Phase 3 Chronic Pain Program For Tanezumab pfizer.com ↗
Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) announced today that they are preparing to resume the Phase 3 clinical program for tanezumab. |
All press releases naming this drug 17 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 37 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 202133“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 |
| Known as | PF-04383119 | “Drug: RN624 (PF-04383119)” NCT00394563 ↗ |
| Known as | RN624 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00568321 ↗ |
| 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 |