Drugs / ridaforolimus
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | — | soft-tissue sarcoma, bone sarcoma | 2012-11-29 | “withdrawal of the European application of ridaforolimus for the maintenance treatment of patients with soft tissue sarcoma or primary malignant bone tumor” merck.com ↗ “decision to withdraw the Marketing Authorisation Application (MAA) for ridaforolimus.” merck.com ↗ |
| Rejected (CRL) | US (FDA) | TALTORVIC | soft-tissue sarcoma, bone sarcoma | 2012-06-05 | “issued a complete response letter regarding the New Drug Application (NDA) for ridaforolimus.” merck.com ↗ |
| Filed | US (FDA) | — | soft-tissue sarcoma, bone sarcoma | 2011-10-05 | “Food and Drug Administration (FDA) has accepted for filing and review the New Drug Application (NDA) for ridaforolimus” merck.com ↗ |
| Filed | EU (EMA) | — | soft-tissue sarcoma, bone sarcoma | — | “The FDA and the European Medicines Agency have accepted the company’s applications for the approval of ridaforolimus” merck.com ↗ “The application for Marketing Authorisation for ridaforolimus was accepted by the EMA in August 2011.” merck.com ↗ “The European Medicines Agency had accepted the marketing authorization application for ridaforolimus.” merck.com ↗ |
Trials 37
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 122 trials · 1 met primary | ||||||
| Phase 1 | NCT01431547 | Feb 2012 → Sep 2013 | cancer | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01431534 | Jan 2012 → Aug 2013 | cancer | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 1 | NCT01380184 | Jul → Oct 2011 | cancer of unknown primary site | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01256268 | Jun 2011 → Feb 2016 | endometrial cancer, ovarian cancer | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT01295632 | Feb 2011 → Dec 2013 | cancer of unknown primary site | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01296659 | Feb → Aug 2011 | soft tissue sarcoma | The University of Texas Health Science Center at San Antonio | Withdrawn | No outcome recorded |
| Phase 1 | NCT01243762 | Nov 2010 → Dec 2012 | cancer | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT01169532 | Oct 2010 → Mar 2014 | cancer of unknown primary site, lymphoma | Fox Chase Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01220570 | Sep 2010 → Dec 2012 | breast cancer | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01212627 | Sep 2010 → Dec 2012 | non-small cell lung carcinoma | Angela Taber MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01071304 | Mar → Sep 2010 | refractory malignant neoplasm | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01043887 | Jan → Apr 2010 | liver disorder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00874731 | Apr → Oct 2009 | metastatic malignant neoplasm | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 1 | NCT00781846 | Oct 2008 → Feb 2010 | cancer | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00730379 | Jul 2008 → Nov 2010 | neoplasm | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00694083 | Jun 2008 → Sep 2009 | neoplasm | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00704054 | Jan 2008 → Jun 2010 | cancer | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00288431 | Feb 2006 → Jul 2008 | sarcoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00112372 | May 2005 → Dec 2008 | cancer | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00087451 | Jul 2004 → Nov 2005 | gliosarcoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00060645 | May 2003 → May 2006 | plasma cell myeloma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00060632 | Apr 2003 → Oct 2005 | plasma cell myeloma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 213 trials · 2 missed | ||||||
| Phase 2 | NCT01605396 | Jul 2012 → Feb 2014 | breast neoplasm | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 2 | NCT01234857 | Sep 2010 → Oct 2013 | breast cancer | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 2 | NCT01010672 | Nov 2009 → Sep 2011 | sarcoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00818675 | Mar 2009 → Aug 2012 | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 2 | NCT00836927 | Feb 2009 → Apr 2017 | — | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 2 | NCT00770185 | Nov 2008 → Mar 2012 | endometrial cancer | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 2 | NCT00777959 | Oct 2008 → May 2011 | prostate cancer | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00739830 | Aug 2008 → Feb 2011 | endometrial cancer | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00736970 | Jul 2008 → Jan 2011 | breast cancer | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00122343 | Aug 2005 → Jan 2008 | endometrial cancer | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00110188 | May 2005 → Apr 2007 | prostate cancer | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00093080 | Oct 2004 → Nov 2008 | leiomyosarcoma, liposarcoma, metastatic neoplasm, osteosarcoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00086125 | Jun 2004 → Jun 2006 | leukemia, lymphoma, myelodysplastic syndrome | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT00538239 | Oct 2007 → Oct 2010 | bone sarcoma, soft tissue sarcoma | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase not applicable1 trial · 1 met primary | ||||||
| — | NCT03702608 | Nov 2018 → Mar 2019 | coronary stenosis | Medinol Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2012-11-29 | Merck Sharp & Dohme LLC | Regulatory Merck Provides Update on EU Marketing Authorization Application for Ridaforolimus merck.com ↗
Merck, known as MSD outside the U.S. and Canada, announced today that it has formally notified the European Medicines Agency (EMA) of Merck’s decision to withdraw the Marketing Authorisation Application (MAA) for ridaforolimus. |
| 2012-06-05 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Complete Response Letter from U.S. Food and Drug Administration for Investigational Medicine Ridaforolimus merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for ridaforolimus. |
| 2012-03-20 | Merck Sharp & Dohme LLC | Regulatory Merck and ARIAD Pharmaceuticals Provide Update on FDA Advisory Committee Vote on Investigational Medicine Ridaforolimus for the Treatment of Metastatic Soft-Tissue or Bone Sarcomas merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and ARIAD Pharmaceuticals, Inc., (NASDAQ:ARIA), announced today that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 13 to 1 against the use of the investigational agent ridaforolimus as maintenance therapy for patients with metastatic soft-tissue sarcoma or bone sarcoma whose disease has not progressed after at least four cycles of chemotherapy. |
| 2011-10-05 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts New Drug Application Filing for Ridaforolimus, Investigational mTOR Inhibitor merck.com ↗
The FDA assigned a Standard review classification to this application. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2012-11-29 | Merck Sharp & Dohme LLC | Merck Provides Update on EU Marketing Authorization Application for Ridaforolimus merck.com ↗ |
| 2012-06-05 | Merck Sharp & Dohme LLC | Merck Receives Complete Response Letter from U.S. Food and Drug Administration for Investigational Medicine Ridaforolimus merck.com ↗ |
| 2012-03-20 | Merck Sharp & Dohme LLC | Merck and ARIAD Pharmaceuticals Provide Update on FDA Advisory Committee Vote on Investigational Medicine Ridaforolimus for the Treatment of Metastatic Soft-Tissue or Bone Sarcomas merck.com ↗ |
| 2011-10-05 | Merck Sharp & Dohme LLC | FDA Accepts New Drug Application Filing for Ridaforolimus, Investigational mTOR Inhibitor merck.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ridaforolimus | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01010672 ↗ |
| Known as | AP23573 | “A Study to Evaluate the Effect of Multiple Doses of Ridaforolimus (AP23573; MK-8669) on the Single Dose Pharmacokinetics of Midazolam.” NCT01071304 ↗3“Ridaforolimus (AP23573/MK-8669) in Participants With Taxane-Resistant Androgen-Independent Prostate Cancer (AIPC)(MK-8669-017)” NCT00110188 ↗ “Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009” NCT00730379 ↗ |
| Known as | deforolimus | “Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009.” NCT00777959 ↗3“Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009” NCT00730379 ↗ “ridaforolimus was also known as deforolimus until May 2009” NCT00110188 ↗ “ridaforolimus was also known as deforolimus until May 2009” NCT00836927 ↗ |
| Known as | MK-8669 | “Ridaforolimus (MK-8669) once daily for 5 consecutive days per week and Dalotuzumab (MK-0646) intravenously (IV) once weekly for 2 weeks” NCT01220570 ↗4“A Study to Evaluate the Effect of Multiple Doses of Ridaforolimus (AP23573; MK-8669) on the Single Dose Pharmacokinetics of Midazolam.” NCT01071304 ↗ “Ridaforolimus (AP23573/MK-8669) in Participants With Taxane-Resistant Androgen-Independent Prostate Cancer (AIPC)(MK-8669-017)” NCT00110188 ↗ “Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009” NCT00730379 ↗ “ridaforolimus (MK8669)” NCT00777959 ↗ |
| Action | Inhibit | “an mTOR Inhibitor” NCT00060632 ↗ |
| Modality | Small molecule | — CHEMBL2103839 ↗ |
| Route | Intravenous | “by intravenous infusion” NCT00060632 ↗ |
| Target | MTOR | “an mTOR Inhibitor” NCT00060632 ↗ |