Drugs / Tapentadol
Tapentadol
also known as
CG5503 · Tapentadol Hydrochloride · NUCYNTA · tapentadol ER · BN 200 (BASE) · BN-200 · BN-200 HYDROCHLORIDE · CG-5503 HYDROCHLORIDE · +13 more
Small molecule targets OPRM1, SLC6A2 via activation / inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | NUCYNTA | — | 2023-07-03 – 2024-06-14 | fda.gov ↗ |
| Label expansion | US (FDA) | NUCYNTA ER | — | 2012-08-28 | fda.gov ↗ |
| Approved | US (FDA) | NUCYNTA | — | 2008-11-20 | fda.gov ↗ |
Trials 59
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials · 1 missed | ||||||
| Phase 1 | NCT01615510 | Oct 2012 → Mar 2013 | allesthesia | University Hospital Schleswig-Holstein | Terminated | Missed primary |
| Phase 1 | NCT01309425 | Feb → May 2011 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT01900587 | Jul → Aug 2010 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT01877226 | Sep → Oct 2008 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT03979989 | Sep → Nov 2005 | — | Grünenthal GmbH | Completed | No outcome recorded |
| Phase 1 | NCT03951987 | Feb → Apr 2004 | — | Grünenthal GmbH | Completed | No outcome recorded |
| Phase 1 | NCT03951402 | Mar → Aug 2003 | — | Grünenthal GmbH | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03121547 | May 2015 → Jan 2016 | drug-induced dyskinesia | Frederiksberg University Hospital | Completed | No outcome recorded |
| Phase 29 trials · 1 missed | ||||||
| Phase 2 | NCT02221674 | Nov 2014 → Oct 2016 | — | Grünenthal GmbH | Terminated | No outcome recorded |
| Phase 2 | NCT01729728 | Nov 2012 → Feb 2014 | — | Grünenthal GmbH | Completed | No outcome recorded |
| Phase 2 | NCT01134536 | Oct 2011 → Mar 2013 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01435577 | Sep 2011 → Feb 2012 | toe, misshapen | Grünenthal GmbH | Completed | No outcome recorded |
| Phase 2 | NCT01124617 | Jun 2010 → Apr 2011 | diabetic polyneuropathy, postherpetic neuralgia | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 2 | NCT01124604 | Apr → Dec 2010 | osteoarthritis, knee | Janssen Pharmaceutical K.K. | Completed | Missed primary |
| Phase 2 | NCT00805142 | Nov 2008 → Jul 2009 | cancer | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 2 | NCT00806247 | Jan → Aug 2005 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 2 | NCT00745069 | Jul 2004 → Aug 2005 | chronic pain syndrome, osteoarthritis, knee | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02151682 | Apr 2015 → Oct 2017 | — | Grünenthal GmbH | Completed | No outcome recorded |
| Phase 332 trials · 17 met primary · 1 missed | ||||||
| Phase 3 | NCT02604446 | Sep 2015 → Feb 2019 | arthritic joint disease | St. Olavs Hospital | Completed | Missed primary |
| Phase 3 | NCT02081391 | Feb 2015 → Mar 2019 | — | Grünenthal GmbH | Completed | Met primary |
| Phase 3 | NCT01813890 | Jan 2013 → Jan 2014 | toe, misshapen | Janssen-Cilag International NV | Completed | Met primary |
| Phase 3 | NCT01516008 | Jan 2012 → Feb 2013 | toe, misshapen | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT01264887 | Mar 2011 → May 2014 | cancer, chronic pain syndrome | Grünenthal GmbH | Terminated | No outcome recorded |
| Phase 3 | NCT01165281 | Aug 2010 → Aug 2012 | — | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT01063868 | Jan → Apr 2010 | diabetic polyneuropathy | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01041859 | Dec 2009 → Mar 2011 | diabetic polyneuropathy | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 3 | NCT00986258 | Oct 2009 → Dec 2010 | chronic pain syndrome, neuropathy, painful | Grünenthal GmbH | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT00983385 | Sep 2009 → May 2010 | chronic pain syndrome | Grünenthal GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00983073 | Sep 2009 → Jun 2010 | chronic pain syndrome, osteoarthritis, knee | Grünenthal GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00986180 | Sep 2009 → Dec 2010 | — | Ortho-McNeil Janssen Scientific Affairs, LLC | Completed | Met primary |
| Phase 3 | NCT00982280 | Sep 2009 → May 2010 | chronic pain syndrome, osteoarthritis, knee | Grünenthal GmbH | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00814580 | Dec 2008 → Mar 2010 | — | Ortho-McNeil Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00784277 | Oct 2008 → Jul 2009 | osteoarthritis | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 3 | NCT00771758 | Sep 2008 → Dec 2009 | — | Ortho-McNeil Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00613938 | Feb → Oct 2008 | arthropathy, toe, misshapen | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 3 | NCT00594516 | Dec 2007 → Apr 2008 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 3 | NCT00609466 | Sep 2007 → Feb 2008 | — | Grünenthal GmbH | Completed | Met primary |
| Phase 3 | NCT00472303 | Jul 2007 → Jun 2012 | neoplasm | Grünenthal GmbH | Completed | Met primary |
| Phase 3 | NCT00487435 | Jun 2007 → Jun 2009 | osteoarthritis | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00486811 | Jun 2007 → Jul 2008 | osteoarthritis, knee | Grünenthal GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00505414 | Jun 2007 → Feb 2009 | cancer | Grünenthal GmbH | Terminated | No outcome recorded |
| Phase 3 | NCT00478023 | May 2007 → Feb 2008 | — | Grünenthal GmbH | Completed | Met primary |
| Phase 3 | NCT00455520 | Apr 2007 → Aug 2008 | diabetic polyneuropathy | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 3 | NCT00449176 | Feb 2007 → May 2008 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 3 | NCT00421928 | Jan 2007 → Jul 2008 | osteoarthritis, knee | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 3 | NCT00361504 | Nov 2006 → Jul 2008 | osteoarthritis, hip, osteoarthritis, knee | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00361582 | Oct 2006 → Aug 2007 | osteoarthritis | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00364533 | Oct 2006 → Dec 2007 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT00364546 | Jul 2006 → Jun 2007 | osteoarthritis, sciatica | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00364247 | ? → May 2007 | arthropathy, toe, misshapen | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 46 trials · 2 met primary · 1 missed | ||||||
| Phase 4 | NCT05999890 | Jul → Dec 2021 | — | Kempegowda Institute of Medical Sciences, Bangalore | Completed | No outcome recorded |
| Phase 4 | NCT03604354 | Aug 2018 → Mar 2020 | osteoarthritis, knee | All India Institute of Medical Sciences, Bhubaneswar | Completed | No outcome recorded |
| Phase 4 | NCT03314792 | Dec 2017 → Feb 2019 | uterine disorder | Oslo University Hospital | Completed | Missed primary |
| Phase 4 | NCT01838616 | Apr 2013 → Jan 2014 | neuropathy, painful | Grünenthal GmbH | Completed | Met primary |
| Phase 4 | NCT01631513 | Aug 2012 | chronic pain syndrome, osteoarthritis | Janssen Scientific Affairs, LLC | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT01352741 | Mar 2011 → Jan 2012 | neuropathy, painful | Grünenthal GmbH | Completed | Met primary |
| Phase not applicable3 trials | ||||||
| — | NCT07587645 | Jun → Jul 2024 | — | ISSSTE Hospital Regional "Gral. Ignacio Zaragoza" | Completed | No outcome recorded |
| — | NCT06240390 | May → Aug 2024 | neuropathy, painful | Universidad Europea de Canarias | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT03351517 | Nov 2017 → Aug 2018 | — | All India Institute of Medical Sciences, Bhubaneswar | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT03956134 Comparator | Apr → Jun 2005 | — | Grünenthal GmbH | Completed | No outcome recorded |
| Phase 2 | NCT01725087 Comparator | Nov 2012 → Jul 2014 | — | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT06269770 Comparator | May 2023 → May 2025 | chronic pain syndrome | University of Thessaly | Unknown | No outcome recorded |
| Phase 4 | NCT01458015 Comparator | Oct 2011 → Nov 2013 | peripheral neuropathy | University Hospital Schleswig-Holstein | Terminated | No outcome recorded |
| Phase 4 | NCT01500317 Comparator | May → Oct 2011 | — | Mayo Clinic | Completed | No outcome recorded |
| — | NCT07320781 Comparator | Nov 2024 → Sep 2025 | breast cancer | Shaukat Khanum Memorial Cancer Hospital & Research Centre | Completed | No outcome recorded |
| — | NCT04718116 Comparator | Nov 2022 → Dec 2024 | chronic pain syndrome, neuropathy, painful | Aretaieion University Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-06-13 | BioDelivery Sciences International | Regulatory Collegium Obtains Six Month Extension of U.S. Pediatric Exclusivity for Nucynta Franchise collegiumpharma.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for Nucynta ® and Nucynta ® ER (“the Nucynta Franchise”). |
| 2023-11-07 | BioDelivery Sciences International | Regulatory Collegium Reports Third Quarter 2023 Financial Results collegiumpharma.com ↗
Received U.S. Food and Drug Administration New Patient Population exclusivity for Nucynta, an immediate release formulation of tapentadol, extending the period of U.S. exclusivity from June 27, 2025 , to July 3, 2026 . |
| 2023-08-24 | BioDelivery Sciences International | Regulatory Collegium Announces Extension of Nucynta Regulatory Exclusivity through July 2026 collegiumpharma.com ↗ |
All press releases naming this drug 12 releases
Evidence & citations 28 cited values
Every value below carries the sentence it was read from. 71 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tapentadol | “The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of Tapentadol (CG5503) extended release (ER) (base) compared to placebo in...” NCT00455520 ↗64“This phase 3 study evaluated the efficacy and safety of tapentadol extended release (ER) compared with oxycodone controlled release (CR) for the management of moderate to...” PMID 23937387 ↗ Aug 2013 “The purpose of this study is to evaluate tapentadol Extended Release (ER) in the treatment of moderate to severe chronic pain” NCT01631513 ↗ “Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.” NCT00986180 ↗ “4 ml of the CG5503 infusion solution corresponding to 40 mg CG5503 (tapentadol hydrochloride).” NCT03951987 ↗ “Tapentadol (CG5503), a newly synthesized drug with an immediate release (IR) formulation” NCT00478023 ↗ “Tapentadol (Nucynta®)” NCT06240390 ↗ |
| Known as | BN 200 (BASE) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201776 ↗ |
| Known as | BN-200 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201776 ↗ |
| Known as | BN-200 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201776 ↗ |
| Known as | CG-5503 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201776 ↗ |
| Known as | CG5503 | “This study investigated the pharmacokinetics (how a drug is taken up and excreted from the body), safety, and tolerability of 2 new tapentadol (CG5503) tablet formulations...” NCT03956134 ↗21“The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of Tapentadol (CG5503) extended release (ER) (base) compared to placebo in...” NCT00455520 ↗ “A Randomized, Double-Blind, Parallel-Arm, Placebo and Active Controlled Dose-Ranging Study of the Efficacy and Safety of Multiple Doses of CG5503 (Tapentadol) IR for...” NCT00806247 ↗ “The purpose of this study is to evaluate the dose-proportionality of the pharmacokinetics of tapentadol (CG5503) in healthy Japanese and Korean adult male participants.” NCT01309425 ↗ “The purpose of this study is to evaluate whether tapentadol (CG5503) prolonged-release (PR) tablets at doses of 100-250 mg twice daily provide a better pain relief” NCT00486811 ↗ “Tapentadol (CG5503), a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting analgesic but has a dual mode of action.” NCT00613938 ↗ “Tapentadol (CG5503) is a newly synthesized opioid drug acting as a centrally acting analgesic like opioid analgesics but has a different mode of action.” NCT01813890 ↗ “A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine” NCT00472303 ↗ “CG5503 is a centrally active pain-relieving drug being investigated for the treatment of acute and chronic pain.” NCT00361582 ↗ “CG5503, a newly synthesized drug also acts as a centrally acting analgesic but has a dual mode of action.” NCT00364247 ↗ “orally administrated tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily” NCT00449176 ↗ |
| Known as | CG5503 (BASE) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201776 ↗ |
| Known as | CG5503 IR | “CG5503 IR; tapentadol” NCT00361582 ↗ |
| Known as | JNS024ER | “An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants” NCT01124604 ↗ |
| Known as | NSC-759619 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201776 ↗ |
| Known as | NUCYNTA | “The objectives of this publication are to 1) evaluate the effects of tapentadol (NUCYNTA and NUCYNTA extended release [ER]) on sex hormone concentrations in healthy male...” PMID 25985806 ↗ May 20153“Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.” NCT00986180 ↗ “Tapentadol (Nucynta®)” NCT06240390 ↗ “Nucynta” NCT00983073 ↗ |
| Known as | Nucynta er | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201776 ↗ |
| Known as | NUCYNTA extended release [ER] | “The objectives of this publication are to 1) evaluate the effects of tapentadol (NUCYNTA and NUCYNTA extended release [ER]) on sex hormone concentrations in healthy male...” PMID 25985806 ↗ May 2015 |
| Known as | Palexia | “Palexia” NCT00983073 ↗ |
| Known as | Palexia/depot | “Tapentadol hydrochloride/depot (Palexia/depot®) is a novel, centrally acting, strong analgesic with a dual mechanism of action.” NCT03314792 ↗ |
| Known as | Tapentadol brand name: Nucynta | “Tapentadol brand name: Nucynta” NCT01500317 ↗ |
| Known as | tapentadol ER | “Patients (n = 588) with at least a 3-month history of opioid and/or non-opioid analgesic use for DPN, dissatisfaction with current treatment, and an average pain intensity...” PMID 21162697 ↗ Jan 20111“Please note that tapentadol ER (Extended Release) and tapentadol PR (Prolonged Release) are identical and used interchangeably.” NCT00486811 ↗ |
| Known as | Tapentadol extended release (ER) | “Drug: Tapentadol extended release (ER)” NCT01041859 ↗ |
| Known as | tapentadol HCl | “This study was to evaluate the efficacy and safety of dosing regimens of tapentadol HCl immediate release capsules for the treatment of postoperative pain over a period of 12...” NCT00806247 ↗ |
| Known as | Tapentadol Hydrochloride | “Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no...” NCT00983073 ↗5“The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release (PR)” NCT00982280 ↗ “4 ml of the CG5503 infusion solution corresponding to 40 mg CG5503 (tapentadol hydrochloride).” NCT03951987 ↗ “Tapentadol hydrochloride is a centrally active analgesic (antinociceptive) compound.” NCT00806247 ↗ “100 mg CG5503 (tapentadol hydrochloride) PR tablet.” NCT03951402 ↗ “Drug: Tapentadol Hydrochloride” NCT05999890 ↗ |
| Known as | Tapentadol hydrochloride, JNS024 | “Tapentadol hydrochloride, JNS024” NCT00805142 ↗ |
| Known as | tapentadol PR | “Please note that tapentadol ER (Extended Release) and tapentadol PR (Prolonged Release) are identical and used interchangeably.” NCT00486811 ↗ |
| Action | Activate | “Tapentadol is a centrally acting analgesic with 2 mechanisms of action, μ-opioid receptor agonism and norepinephrine reuptake inhibition, that is available in an...” PMID 23340531 ↗ Jan 20131“Mu opioid receptor agonist” CHEMBL1201776 ↗ |
| Action | Inhibit | “Norepinephrine transporter inhibitor” CHEMBL1201776 ↗ |
| Modality | Small molecule | — CHEMBL1201776 ↗ |
| Route | Oral | “Patients were randomized 4:1 to receive controlled, adjustable, oral, twice-daily doses of tapentadol ER (100 to 250 mg) or oxycodone HCl controlled release (CR; 20 to 50 mg)...” PMID 20602712 ↗ Sep 2010 |
| Target | OPRM1 | “Mu opioid receptor agonist” CHEMBL1201776 ↗ |
| Target | SLC6A2 | “Norepinephrine transporter inhibitor” CHEMBL1201776 ↗ |