Nucynta

(Tapentadol)

ApprovedSmall molecule

Tapentadol is used to treat moderate to severe pain, including chronic pain conditions like diabetic nerve pain. It works by reducing how the brain perceives pain signals.[2] Nucynta is currently approved and in use across 13 indications[4].[1]

Nucynta is one of 212 small molecule programs targeting Low back pain. It is currently in Approved.

Indications

Total Trials

Active Trials

211

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Low Back PainCompleted

Pain AgnosiaActive, not recruiting

Osteoarthritis, KneeApproved

Osteoarthritis, HipApproved

Diabetic NeuropathyApproved

Joint DiseaseApproved

Neuropathic PainApproved

Back PainApproved

Hallux ValgusApproved

Cancer PainActive, not recruiting

Low Back PainApproved

Completed

Pain AgnosiaPreclinical

Active, not recruiting

Osteoarthritis, KneeApproved

Approved

Osteoarthritis, HipApproved

Approved

Diabetic NeuropathyApproved

Approved

Joint DiseaseApproved

Approved

Neuropathic PainApproved

Approved

Back PainApproved

Approved

Hallux ValgusApproved

Approved

Cancer PainPreclinical

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

66 competitors in Total Knee Arthroplasty

#DrugCompanyPhaseTrials

Cyklokapron

JJ Molner

Approved

26 2

Naropin

FFresenius Kabi USA, LLC

Approved

26 3

Marcaine

IInnocoll

Approved

18 4

Carbocaine

Pfizer

Approved

3 5

Epidiolex

Jazz Pharmaceuticals

Approved

1 6

Journavx

Vertex Pharmaceuticals

Approved

1 7

Lexapro

AbbVie

Approved

1 8

MS Contin

HHikma Pharmaceuticals LLC

Approved

7 9

Duragesic

CCephalon

Approved

7 10

Adrenaline

SSamson Clinical Operations Pty Ltd

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2029

Active, not recruiting

Arthroscopic Rotator Cuff Repair (ARCR)

NCT07779473

Clinical

Trials by Indication[1]

Low back pain4 trials

Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.

Completed·TTris Pharma, Inc.·Phase 2·NCT01725087·1,089 enrolled

Tapentadol Prolonged Release (PR) Versus Oxycodone/Naloxone Prolonged Release in Severe Chronic Low Back Pain With a Neuropathic Component.

Completed·GGrünenthal GmbH·Phase 4·NCT01838616·367 enrolled

Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability

Terminated·GGrünenthal GmbH·Phase 3·NCT00986258·136 enrolled

Show 1 more trial

Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00594516·117 enrolled

Total Knee Arthroplasty2 trials

Tapentadol vs Tramadol in Total Knee Arthroplasty

Recruiting·UUniversity of Thessaly·Phase 4·NCT06269770·96 enrolled

Preemptive Tapentadol on Post-operative Analgesia Following Total Knee Arthroplasty

Completed·—·N/A·NCT03351517·90 enrolled

Peripheral Neuropathy2 trials

A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT01041859·460 enrolled

A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)

Terminated· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT01063868·47 enrolled

Adolescent2 trials

A Study to Look at Tapentadol Tablets in Children and Adolescents in Pain

Completed·GGrünenthal GmbH·Phase 2/3·NCT02151682·73 enrolled

Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01134536·45 enrolled

Gastrointestinal1 trial

Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans

Completed·MMayo Clinic·Phase 4·NCT01500317·38 enrolled

20 more indications

Osteoarthritis1 trial

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 Regular Analgesic

Completed·GGrünenthal GmbH·Phase 3·NCT00983073·224 enrolled

Efficacy and Safety1 trial

Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain

Completed·GGrünenthal GmbH·Phase 2·NCT01729728·86 enrolled

Pain After Surgery1 trial

Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old

Terminated·GGrünenthal GmbH·Phase 2·NCT02221674·40 enrolled

Cancer Pain1 trial

Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research··NCT01946555·150 enrolled

Preoperative1 trial

Role of Preoperative Tapentadol in Reduction of Perioperative Analgesic Requirement After Breast Conservative Surgery in Cancer Patients.

Completed·SShaukat Khanum Memorial Cancer Hospital & Research Centre·N/A·NCT07320781·70 enrolled

Postoperative Pain Relief1 trial

Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty.Tapentadol vs Oxycodone vs Placebo

Completed·SSt. Olavs Hospital·Phase 3·NCT02604446·134 enrolled

Intravenous1 trial

Intravenous Tapentadol in Post-Bunionectomy Pain

Completed·GGrünenthal GmbH·Phase 2·NCT01435577·177 enrolled

Treatment1 trial

A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine

Completed·GGrünenthal GmbH·Phase 3·NCT00472303·622 enrolled

Effectiveness1 trial

A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00613938·901 enrolled

Pregabalin1 trial

Comparison of Increasing Doses of Tapentadol Versus a Combination of Tapentadol and Pregabalin

Completed·GGrünenthal GmbH·Phase 4·NCT01352741·622 enrolled

Malignant Tumour1 trial

Tapentadol in Chronic Malignant Tumour Related Pain

Terminated·GGrünenthal GmbH·Phase 3·NCT01264887·31 enrolled

Experimental1 trial

Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models

Terminated·UUniversity Hospital Schleswig-Holstein·Phase 1·NCT01615510·24 enrolled

Chronic pain1 trial

An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00487435·1,166 enrolled

Opioid1 trial

Opioid Induced Gait Variability

Completed·FFrederiksberg University Hospital·Phase 1/2·NCT03121547·24 enrolled

Post Operative Pain1 trial

Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Surgery

Completed·—·Phase 4·NCT03604354·95 enrolled

Prolonged1 trial

Phase 1 Pharmacokinetic Study of Tapentadol Prolonged-Release 250 Milligram (mg) Formulation in Healthy Participants

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01877226·18 enrolled

Postherpetic Neuralgia1 trial

A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01124617·91 enrolled

Hysterectomy1 trial

Effects of Tapentadol Versus Oxycodone After Hysterectomy.

Completed·OOslo University Hospital·Phase 4·NCT03314792·86 enrolled

Arthroscopic Rotator Cuff Repair (ARCR)1 trial

Comparison of Tramadol vs Tapentadol as Postoperative Analgesia in Arthroscopic Rotator Cuff Repair Surgery

Active, not recruiting·UUniversity of Thessaly··NCT07779473·64 enrolled

Unspecified1 trial

Tapentadol (CG5503)

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00421928·1,030 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 20, 2008

NUCYNTA

NDA NDA022304

Aug 25, 2011

NUCYNTA ER

NDA NDA200533

Oct 15, 2012

NUCYNTA

NDA NDA203794

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Tapentadol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nucynta drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tapentadol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tapentadol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA203794). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Nucynta. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Collegium Pharmaceutical, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Norepinephrine Transporter Inhibitor; Mu Opioid Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CCollegium Pharmaceutical, Inc.

Patent Landscape[6]

Patent Cliff

Apr 21, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11344512Apr 21, 2028

8536130Sep 22, 2028

11344512*PEDOct 21, 2028

8536130*PEDMar 22, 2029

Nucynta

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2029

Trials by Indication[1]

Low back pain4 trials

Total Knee Arthroplasty2 trials

Peripheral Neuropathy2 trials

Adolescent2 trials

Gastrointestinal1 trial

Osteoarthritis1 trial

Efficacy and Safety1 trial

Pain After Surgery1 trial

Cancer Pain1 trial

Preoperative1 trial

Postoperative Pain Relief1 trial

Intravenous1 trial

Treatment1 trial

Effectiveness1 trial

Pregabalin1 trial

Malignant Tumour1 trial

Experimental1 trial

Chronic pain1 trial

Opioid1 trial

Post Operative Pain1 trial

Prolonged1 trial

Postherpetic Neuralgia1 trial

Hysterectomy1 trial

Arthroscopic Rotator Cuff Repair (ARCR)1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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