Ultram

(Tramadol)

ApprovedSmall molecule

Tramadol is used to treat moderate to moderately severe pain. It works by changing how your body senses and responds to pain.[2] Ultram is currently approved and in use across 42 indications[4].[1]

Ultram is one of 863 small molecule programs targeting Acute Pancreatitis. It is currently in Approved.

Indications

153

Total Trials

Active Trials

862

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Acute PancreatitisActive, not recruiting

ContraceptionApproved

Peritonsillar AbscessActive, not recruiting

Neuropathic PainActive, not recruiting

Low Back PainApproved

Rheumatic DiseaseActive, not recruiting

AdenomaActive, not recruiting

Hip FractureApproved

AppendicitisActive, not recruiting

Substance Withdrawal SyndromeApproved

Acute PancreatitisPhase 1

Active, not recruiting

ContraceptionApproved

Approved

Peritonsillar AbscessPreclinical

Active, not recruiting

Neuropathic PainPhase 3

Active, not recruiting

Low Back PainApproved

Approved

Rheumatic DiseasePreclinical

Active, not recruiting

AdenomaPreclinical

Active, not recruiting

Hip FractureApproved

Approved

AppendicitisPreclinical

Active, not recruiting

Substance Withdrawal SyndromeApproved

Approved

Showing 10 of 39 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Ultram

WWim Janssens

Approved

1 2

Tecentriq

Roche

Preclinical

36 3

Trodelvy

Gilead

Preclinical

37 4

Halaven

Eisai

Preclinical

38 5

Tykerb

GSK

Preclinical

80 6

Adriamycin

GGynecologic Oncology Group

Preclinical

87 7

Avastin

BBio-Thera Solutions

Preclinical

153 8

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 9

Prolia

Amgen

Preclinical

14 10

Gemzar

GGynecologic Oncology Group

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Post-ApprovalActive, not recruiting

Shoulder Arthroplasty

NCT05488847

Q4 2026

N/AActive, not recruiting

Epidural Analgesia

NCT07346872

Post-ApprovalNot yet recruiting

Hip Fracture

NCT07066111

Phase 2Active, not recruiting

Abdominal Cancer Surgery

NCT06232577

Q2 2027

Phase 3Not yet recruiting

Efficacy and Safety

NCT06237231

Q4 2027

N/ARecruiting

Adverse Effect

NCT07264309

Clinical

Trials by Indication[1]

Tramadol10 trials

Tramadol and Pain Sensitization

Completed·UUniversity Hospital, Clermont-Ferrand·Phase 1·NCT00487175·12 enrolled

Tramadol to Improve Its Detection in Biological Matrices in Anti-doping Controls

Completed·PParc de Salut Mar·Phase 1·NCT05925686·25 enrolled

Tramadol vs.Tramadol With Paracetamol

Completed·YYeditepe University Hospital·N/A·NCT03482492·60 enrolled

Show 7 more trials

Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

Completed·UUniversity of Malaya·Phase 2·NCT03383315·191 enrolled

The Discriminative Effects of Tramadol in Humans

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1/2·NCT00499746·20 enrolled

The Influence of Tramadol on Opioid-induced Bowel Dysfunction

Completed·AAsbjørn Mohr Drewes·Phase 2·NCT06385561·20 enrolled

Short-term Perfusion Effects: Dexketoprofen/Tramadol

Completed·—·N/A·NCT07386288·102 enrolled

PK PD of the Enantiomers of Tramadol and O-desmethyltramadol in Elderly and Young Subjects

Completed·UUniversité de Montréal·Phase 1·NCT02329561·35 enrolled

Penthrox Versus Tramadol for SCDF

Completed·SSingapore General Hospital·Phase 4·NCT01887951·380 enrolled

Effect of Oral Tramadol Administration Prior to IUD Insertion

Unknown status·—·Phase 3·NCT04312061·108 enrolled

Post Operative Pain7 trials

Evaluate Safety of Tramadol in the Management of Postoperative Pain Following Surgery

Completed·AAvenue Therapeutics, Inc.·Phase 3·NCT03395808·251 enrolled

Intravenous Paracetamol for Postoperative Pain

Completed·LLithuanian University of Health Sciences·Phase 4·NCT02248493·54 enrolled

Preemptive Oral Gabapentin and Tramadol on Postoperative Pain After Knee Arthroscopy

Completed·TTanta University·N/A·NCT06112223·50 enrolled

Show 4 more trials

Tramadol Versus Placebo and Morphine in the Management of Post-Operative Pain Abdominoplasty

Active, not recruiting·AAvenue Therapeutics, Inc.·Phase 3·NCT03774836·360 enrolled

Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy

Completed·AAvenue Therapeutics, Inc.·Phase 3·NCT03290378·409 enrolled

Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption in Shoulder Surgery

Completed·—·N/A·NCT05401916·2 enrolled

Analgesic Equivalence of NSAIDs and a Weak Opioid in Acute Postoperative Pain Following Minimally Invasive Surgery Under Balanced General Anaesthesia: A Pilot Randomised Controlled Trial

Completed·IISSSTE Hospital Regional "Gral. Ignacio Zaragoza"·Preclinical·NCT07500454·30 enrolled

Hysteroscopy7 trials

Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy

Unknown status·—·Phase 3·NCT02736071·210 enrolled

Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy:

Unknown status·—·Phase 3·NCT02760888·102 enrolled

Tramadol Versus Diclofenac for Prevention of Pain in Operative Outpatient Hysteroscopy

Unknown status·—·Phase 3·NCT02428777·210 enrolled

Show 4 more trials

Tramadol Versus Celecoxib for Reducing Pain in Outpatient Hysteroscopy

Completed·—·Phase 2·NCT02071303·210 enrolled

Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy

Unknown status·—·Phase 3·NCT03585036·210 enrolled

Evaluation of the Role of Tramadol 50mg as an Analgesic During Outpatient Hysteroscopy

Completed·—·Phase 2·NCT02068209·140 enrolled

Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy

Unknown status·—·Phase 3·NCT02419651·210 enrolled

Postoperative Analgesia6 trials

Efficacy of Extended-release, Once Daily Tramadol for Post Operative Analgesia in Shoulder Arthroscopy

Terminated·—·Phase 2·NCT02247648·100 enrolled

Nalbuphine Versus Tramadol on Post Operative Analgesia in Abdominal Surgery on Pediatric Cancer Patient

Recruiting·NNational Cancer Institute, Egypt·N/A·NCT07110051·128 enrolled

Perioperative Electroacupuncture on Postoperative Analgesia in Prostatectomy

Completed·GG.Gennimatas General Hospital·Phase 4·NCT01526525·70 enrolled

Show 3 more trials

Tramadol in Penial Block Does it Improve Efficiency of Postoperative Analgesia in Circumcision

Completed·LLeila mansali stambouli·N/A·NCT03260439·106 enrolled

USG-Guided Infiltration Popliteal Artery Capsule Knee Block Versus Adductor Canal Block Application as Postoperative Analgesia

Completed·SSiirt Training and Research Hospital·Phase 4·NCT05956275·20 enrolled

Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthroscopy

Active, not recruiting·Mmedina medical center·Phase 4·NCT06742554·70 enrolled

Analgesia4 trials

SPI-directed Analgesia for Lumbar Discectomy

Completed·MMedical University of Silesia·N/A·NCT02971540·132 enrolled

Tramadol for Labour Analgesia in Low Risk Primiparous Women

Completed·SSaint Thomas Hospital, Panama·Phase 3·NCT01889979·100 enrolled

Effect of Transversus Thoracic Muscle Plane Block (TTMP) on Analgesia

Completed·IIstanbul University - Cerrahpasa·Phase 4·NCT06601530·46 enrolled

Show 1 more trial

Tramadol Versus Fentanyl for Post-Operative Analgesia in Newborn Infants

Completed·FFederal University of São Paulo·Phase 3·NCT00713726·160 enrolled

90 more indications

Analgesic4 trials

MAST Trial: Multi-modal Analgesic Strategies in Trauma

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT03472469·1,561 enrolled

Effect of Oral Analgesics on Post-op Pain

Completed·—·Phase 1·NCT07204379·100 enrolled

Omnitram Pharmacokinetic and Analgesic Study Following CY2D6 Inhibition With Paroxetine In Healthy Volunteers

Completed·SSyntrix Biosystems, Inc.·Phase 1·NCT03312777·60 enrolled

Show 1 more trial

Minimizing Narcotic Analgesics After Endocrine Surgery

Completed·MMinerva A Romero Arenas·Phase 4·NCT03469310·126 enrolled

Cesarean Section3 trials

Comparing Protocols for Analgesia Following Elective Cesarean Section

Unknown status·WWolfson Medical Center·Phase 4·NCT03622489·120 enrolled

Compair Efficacy of iv Dexmedetomidine & Tramadol for Post Spinal Shivering in Obs Patients Undergoing Cesarean Section

Unknown status·SSana Bahadur·Phase 2·NCT05616364·100 enrolled

Trans Abdominis Plane (TAP) Block in Patients With Cesarean Section

Unknown status·—·N/A·NCT04809532·60 enrolled

Post Spinal Anesthesia Shivering3 trials

Use of Iv Tramadol and Ketamine for Prevention of Post Spinal Anesthesia Shivering

Recruiting·LLiaquat National Hospital & Medical College·Phase 3·NCT06722742·250 enrolled

Comparison of Prophylactic Use of Tramadol Versus Ketamine for Prevention of Post Spinal Anesthesia Shivering

Completed·SSyed Muhammad Abbas·Phase 3·NCT07043049·92 enrolled

Comparsion of IV Dexmedetomidine, Tramdol and Ketamine for Post Spinal Anesthesia Shivering.

Unknown status·SSheikh Zayed Medical College·Phase 3·NCT05311722·71 enrolled

Acute Postoperative Pain3 trials

Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy

Completed·VViatris Specialty LLC·Phase 3·NCT06215859·579 enrolled

Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy

Completed·VViatris Specialty LLC·Phase 3·NCT06215820·410 enrolled

Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain

Completed·LLaboratorios Liomont·Phase 2·NCT05995912·58 enrolled

Efficacy and Safety3 trials

Efficacy and Safety of DIT112 in the Treatment of Moderate to Severe Pain After Dental Surgery for the Extraction of Impacted Third Molars

Not yet recruiting·EEMS·Phase 3·NCT06237231·252 enrolled

Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain

Withdrawn·EEMS·Phase 2·NCT04593329

Efficacy and Safety in a Randomised Acute Pain Study of MR308 (Tramadol/Celecoxib).

Completed·MMundipharma Research GmbH & Co KG·Phase 3·NCT02982161·818 enrolled

Pain Management3 trials

Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women

Unknown status·MMeir Medical Center·Phase 4·NCT02706509·100 enrolled

Transversus Abdominis Plane Block Versus Ilioinguinal Nerve Block for Pain Management in Inguinal Herniorraphy

Completed·—·N/A·NCT02375100·90 enrolled

The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral TKA

Completed·—·N/A·NCT06112548·80 enrolled

Neuropathic Pain2 trials

Treatment of Neuropathic Pain in Leprosy

Unknown status·UUniversity of Sao Paulo·Phase 3·NCT03324035·102 enrolled

The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma

Withdrawn·MMasaryk University·Phase 3·NCT03255330

Tonsillectomy2 trials

Comparison of Peritonsillar Infiltration of Tramadol Ketamine and Placebo on Pediatric Posttonsillectomy Pain

Unknown status·UUniversidade Federal de Goias·Phase 4·NCT03067103·108 enrolled

A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy

Completed·—·Phase 4·NCT01267136·84 enrolled

Laparoscopic Cholecystectomy2 trials

Evaluation of the Efficacy of Regional Anaesthesia for Analgesia After Laparoscopic Cholecystectomy

Completed·—·N/A·NCT06008002·90 enrolled

Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy

Completed·—·Phase 4·NCT02327923·90 enrolled

Osteoarthritis2 trials

A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb

Completed· Pfizer logo

Pfizer·Phase 1·NCT00743587·36 enrolled

Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip Knee and/or Lumbar Spine

Completed·NNorpharma A/S·Phase 4·NCT00426647·120 enrolled

Hip Fracture2 trials

The Effect of Bupivacaine Liposome Preemptive Analgesia on Postoperative Pain and Delirium in Elderly Patients Undergoing Hip Fracture Surgery

Not yet recruiting·NNanjing First Hospital, Nanjing Medical University·Phase 4·NCT07066111·40 enrolled

Fascia Iliaca Compartment Block and Tramadol for Analgesia in Hip Fracture

Not yet recruiting·WWest China Hospital·N/A·NCT06728033·240 enrolled

Ibuprofen2 trials

Pain Relief - Tramadol Versus Ibuprofen

Unknown status·RRoyal Liverpool University Hospital·Phase 1/2·NCT00111046·40 enrolled

Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen

Terminated·—·Phase 4·NCT02076893·64 enrolled

Prevention2 trials

Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering

Unknown status·LLagos State Health Service Commission·Phase 2·NCT02441673·130 enrolled

DPNB for Prevention of CRDB

Completed·WWest China Hospital·Phase 3·NCT01721031·58 enrolled

Pain Control2 trials

NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow

Recruiting·TThe Cleveland Clinic·Phase 4·NCT06373978·92 enrolled

A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair

Completed·SSeoul National University Bundang Hospital·Phase 4·NCT02850211·180 enrolled

Opioid Withdrawal2 trials

Tramadol to Reduce Opioid Withdrawal Symptoms

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00142896·16 enrolled

Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

Completed·MMichelle Lofwall·Phase 2/3·NCT00980044·53 enrolled

Treatment2 trials

Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch

Completed· Astellas logo

Astellas·Phase 4·NCT01416116·122 enrolled

Comparison of Three Opioid Detoxification Treatment Regimens

Withdrawn·UUniversity of Alabama at Birmingham·Phase 3·NCT03678792

Abdominal Surgery2 trials

Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery

Completed·—·Phase 2·NCT02703415·60 enrolled

A Comparison Study Between Ketamine Versus Tramadol for Pain Management After Major Upper Abdominal Surgery

Completed·—·N/A·NCT02499341·42 enrolled

Total Knee Arthroplasty2 trials

Tapentadol vs Tramadol in Total Knee Arthroplasty

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

The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty

Completed·RRothman Institute Orthopaedics·N/A·NCT04003350·216 enrolled

Shoulder Arthroplasty2 trials

Opioid-Free Pain Protocol After Shoulder Arthroplasty

Active, not recruiting·HHenry Ford Health System·Phase 4·NCT05488847·83 enrolled

Multimodal Analgesia in Shoulder Arthroplasty

Withdrawn·RRush University Medical Center·Phase 3·NCT03586934

Menopausal Women2 trials

Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy in Post Menopausal Women

Unknown status·—·Phase 3·NCT02425709·210 enrolled

Tramadol Versus Celecoxib for Reducing Pain During Office Hysteroscopy in Post Menopausal Women

Unknown status·—·Phase 3·NCT02736019·210 enrolled

Bone Fracture1 trial

RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child

Completed·IIRCCS Burlo Garofolo·Phase 4·NCT00560443·133 enrolled

Mucositis1 trial

Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients

Completed·MMedical College of Wisconsin·Phase 2·NCT04752384·20 enrolled

Vascular Function1 trial

Effects of Opioids and NSAIDs on Sympathetic Nervous System and Vascular Function

Recruiting·UUniversity of Zurich·Phase 4·NCT03781544·90 enrolled

ACL Reconstruction1 trial

Impact of Opioid Avoidance Protocol for ACL Reconstruction

Completed·MMatthew Varacallo··NCT06340932·32 enrolled

Multimodal Analgesia1 trial

Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery

Completed·—·Phase 4·NCT04110665·92 enrolled

Spinal Anesthesia1 trial

Tramadol and Tramadol Plus Ketamine for Shivering Prevention After Spinal Anesthesia in Lower Segment Caeserian Section

Unknown status·ZZiauddin University·Phase 4·NCT06134895·190 enrolled

Perioperative Pain Control1 trial

Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

Unknown status·UUniversity of Illinois College of Medicine at Peoria·Phase 4·NCT02958566·80 enrolled

Hallux valgus1 trial

The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery

Completed·KKarolinska Institutet·Phase 4·NCT00733421·100 enrolled

Adverse Effect1 trial

Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor. Compare the Efficacy and Adverse Effects

Recruiting·ZZohar Nachum·N/A·NCT07264309·140 enrolled

Breast Cancer1 trial

The Impact of Intravenous Anaesthesia on Angiogenesis in Patients With Breast Cancer (TIVA/TCI-BC)

Completed·IIuliu Hatieganu University of Medicine and Pharmacy·Phase 2·NCT02839668·120 enrolled

Infiltration1 trial

Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty

Completed·FFederal University of São Paulo·Phase 4·NCT01943760·40 enrolled

Intravenous1 trial

Intravenous Tramadol and Magnesium Sulphate for Prevention of Shivering

Not yet recruiting·—·Phase 4·NCT06612996·180 enrolled

Rectus Sheath Block1 trial

Ultrasound-guided Rectus Sheath Block In Children

Completed·—·Phase 4·NCT02291705·40 enrolled

Unknown status·—·Phase 4·NCT02827487·210 enrolled

Postoperative Pain Control1 trial

Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery

Completed·SSeoul National University Hospital·Phase 4·NCT02416804·69 enrolled

Pregabalin1 trial

Efficacy, Safety, Tolerability and Pharmacokinetics of Concomitant Administration of Tramadol With Duloxetine or Pregabalin

Withdrawn·TTurku University Hospital·Phase 4·NCT01116531

Dental Implant1 trial

OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients

Completed·HHersh, Elliot V., DMD, MS, PhD·Phase 4·NCT04694300·30 enrolled

Buprenorphine1 trial

Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair

Completed·HHospital Italiano de Buenos Aires·Phase 2/3·NCT03380533·50 enrolled

Thoracotomy1 trial

Effect of Continue RISS Block in Thoracotomy

Completed·KKonya Meram State Hospital·N/A·NCT04443556·40 enrolled

Abortion1 trial

Comparison of Tramadol vs Remifentanyl Patient Controlled Analgesia for Second Trimester Abortions

Completed·RRabin Medical Center·N/A·NCT00361686·40 enrolled

Platelet Function1 trial

The Influence of Tramadol on Platelet Function

Completed·MMedical University of Graz·Phase 4·NCT05237492·33 enrolled

Sternotomy1 trial

Advantage of Tramadol in Local Analgesia Post-Sternotomy

Completed·—·Phase 4·NCT02851394·160 enrolled

Adenoma1 trial

Pain Management After Transnasal Transsphenoidal Surgery for Pituitary Adenomas

Unknown status·PPeking Union Medical College Hospital·N/A·NCT04611685·202 enrolled

Shoulder pain1 trial

Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain

Completed·UUniversity of Debrecen·Phase 4·NCT02445599·3 enrolled

Laparoscopic Cholecystectomy Surgery1 trial

Analgesic Effect of Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery

Completed·—·N/A·NCT03308955·60 enrolled

Major Trauma1 trial

Pain Multidisciplinar Intervention in Major Trauma Patients

Completed·NNuria Llorach-Perucho··NCT05355441·38 enrolled

Sleep Apnea1 trial

Impact of Tramadol and Oxycodone on Sleep Apnea

Completed·—·Phase 4·NCT03454217·60 enrolled

Post-Traumatic Stress Disorder, PTSD1 trial

Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)

Completed·IINTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium·Phase 4·NCT01517711·40 enrolled

Opioid Addiction1 trial

Assessment of Tramadol as a Treatment for Opioid Addiction

Completed·JJohns Hopkins University·Phase 1/2·NCT00301210·9 enrolled

Caesarean Section1 trial

COMPARISON OF INTRAVENOUS DEXMEDETOMEDINE AND TRAMADOL FOR POST OPERATIVE SHIVERING AFTER SPINAL ANESTHESIA FOR CAESAREAN SECTION

Completed·LLiaquat National Hospital & Medical College·Phase 4·NCT07332572·100 enrolled

Function1 trial

The Effect of Naldemedine on Opioid-induced Bowel Dysfunction

Recruiting·AAsbjørn Mohr Drewes·Phase 2·NCT06334198·20 enrolled

Metabolism1 trial

Paroxetines Effect on Tramadols Metabolism and Pharmakodynamics: a Dose Response Study

Unknown status·UUniversity of Southern Denmark·Phase 4·NCT00785603·12 enrolled

Postpartum Depression1 trial

Effect of Tramadol in Prevention of Postpartum Depression

Completed·XXinqiao Hospital of Chongqing·Phase 4·NCT03309163·1,230 enrolled

Sinus Surgery1 trial

Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery

Completed·RRecep Tayyip Erdogan University·Phase 4·NCT02484859·88 enrolled

Appendicitis1 trial

Management of Acute Appendicitis Pain in the Emergency Department

Completed·—··NCT06808087·96 enrolled

Abdominal Cancer Surgery1 trial

5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06232577·170 enrolled

Lidocaine Infusion1 trial

The Effect of Intrauterine Lidocaine Infusion and Oral Tramadol on Pain During Diagnostic Office Hysteroscopy

Completed·—·Phase 4·NCT03701984·156 enrolled

Muscle weakness1 trial

Does Gabapentin Reduce Quadriceps Muscle Weakness After Anterior Cruciate Ligament Reconstruction?

Unknown status·HHospital Authority, Hong Kong·Phase 2/3·NCT03496389·30 enrolled

Dexmedetomidine1 trial

Comparison of Tramadol and Dexmedetomidine in the Prevention of Urinary Catheter Discomfort in Urinary Surgery

Completed·—·N/A·NCT04314050·135 enrolled

COVID-191 trial

Safety and Efficacy of Tramadol in COVID-19 Egyptian Patients

Unknown status·TTanta University·Phase 1/2·NCT04454307·100 enrolled

Tolerance1 trial

Effect of Increased Pain Tolerance on Exercise Performance

Completed·UUniversity of Copenhagen·N/A·NCT03934411·16 enrolled

Children1 trial

Study to Compare Gabapentin to Tramadol in Children With Chronic Neuropathic or Mixed Pain

Terminated·PPharmaceutical Research Management srl·Phase 3·NCT02722603·2 enrolled

Acute Pancreatitis1 trial

"NSAIDs vs. Opiates: Which is More Effective in Managing Pain in Mild to Moderate Acute Pancreatitis?

Unknown status·HHayatabad Medical Complex·Phase 1·NCT05756504·130 enrolled

Local Anesthesia1 trial

Bupivacaine Alone vs Bupivacaine With Tramadol in Local Anesthesia Procedures

Completed·JJinnah Postgraduate Medical Centre·Phase 3·NCT07469826·100 enrolled

Preoperative1 trial

Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block.

Completed·FFarjad Zafar·Phase 4·NCT05488925·120 enrolled

Burn Wound1 trial

Heparin for the Treatment of Burn Wound Pain

Unknown status·KKing Edward Medical University·N/A·NCT02497326·36 enrolled

Endodontic Treatment1 trial

The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment

Completed·—·Phase 1/2·NCT01178203

Dysmenorrhea1 trial

Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea

Completed·—·Phase 4·NCT03509740·100 enrolled

Sedation1 trial

Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)

Completed·AAvanti Anesthesia·N/A·NCT03653520·651 enrolled

Randomized Controlled Trial1 trial

Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery

Completed·GGZA Ziekenhuizen Campus Sint-Augustinus·Phase 4·NCT02544282·140 enrolled

Epidural Analgesia1 trial

EXORA Block vs Epidural Analgesia in Gynecological Surgery

Active, not recruiting·—·N/A·NCT07346872·60 enrolled

Analgesic Efficacy1 trial

The Analgesic Efficacy of Wound Infiltration With Tramadol

Completed·YYeditepe University Hospital·Phase 4·NCT02518438·60 enrolled

Abdominal pain1 trial

Sublingual Analgesia for Acute Abdominal Pain in Children

Completed·IIRCCS Burlo Garofolo·Phase 3·NCT02465255·210 enrolled

Premedication1 trial

Premedication for ERCP With Midazolam or Tramadol

Completed·KKaradeniz Technical University·Phase 4·NCT02436980·40 enrolled

Opioid Use Disorder1 trial

PROUD Study - Preventing Opioid Use Disorders

Terminated·EEmory University·Phase 4·NCT04766996·57 enrolled

Cancer Pain1 trial

Efficacy of Duloxetine in Conjunction With Tramadol for Chronic Cancer Pain

Completed·—·N/A·NCT05311774·400 enrolled

Fibromyalgia1 trial

Combined Behavioral and Analgesic Trial for Fibromyalgia

Completed·UUniversity of Washington·Phase 3·NCT01598753·134 enrolled

Abuse Potential1 trial

Assessment of Abuse Potential of Cebranopadol in Humans

Completed·TTris Pharma, Inc.·Phase 1·NCT05256108·38 enrolled

Clinical Trial1 trial

Co-crystal E-58425 vs Tramadol and Celecoxib for Moderate to Severe Acute Pain After Bunionectomy. Phase III Clinical Trial.

Completed·EEsteve Pharmaceuticals, S.A.·Phase 3·NCT03108482·637 enrolled

Tics1 trial

Pain Study to See if Ultram ER Will Provide Relief to Subjects Whose Pain is Not Well Controlled by Narcotics

Terminated·MMassachusetts General Hospital··NCT00505531·7 enrolled

Nerve Block1 trial

Pudendal Nerve Block for Catheter-related Bladder Discomfort Prevention

Unknown status·WWest China Hospital·N/A·NCT02683070·94 enrolled

Single Dose1 trial

Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery

Completed·—·Phase 4·NCT02964416·80 enrolled

Genetic Polymorphism1 trial

Impact of Genetic Polymorphism on Drug-Drug Interactions Involving CYP2D6

Completed·JJules Desmeules·N/A·NCT03054220·34 enrolled

Interaction1 trial

Non-interaction Study Between Pregabalin and Tramadol, Administered Individually or Combination, in Healthy Subjects

Completed·LLaboratorios Silanes S.A. de C.V.·Phase 1·NCT05389150·30 enrolled

Pulpitis1 trial

Effect of Preoperative Oral Tramadol on Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis

Completed·—·N/A·NCT04961268·250 enrolled

Knee Arthroscopy1 trial

Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy

Unknown status·SShaare Zedek Medical Center·N/A·NCT01024348·100 enrolled

Symptomatic Irreversible Pulpitis1 trial

Effect of Preoperative Tramadol and Naproxen Sodium on Efficacy of Local Anesthesia and Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis

Completed·DDow University of Health Sciences·Preclinical·NCT05982392·139 enrolled

Unspecified3 trials

Omnitram Pharmacokinetic Study In Healthy Volunteers

Completed·SSyntrix Biosystems, Inc.·Phase 1·NCT02205554·43 enrolled

Rhomboid Intercostal and Subserratus Plane Block

Completed·—·N/A·NCT04761029·50 enrolled

Development of Cocktail for Measuring the Activity of Important Cytochrome P450 Enzymes

Terminated·UUniversity of Southern Denmark·N/A·NCT00981929·412 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 3, 1995

ULTRAM

NDA NDA020281

May 5, 2005

RYBIX ODT

NDA NDA021693

Sep 8, 2005

ULTRAM ER

NDA NDA021692

Dec 30, 2008

RYZOLT

NDA NDA021745

May 7, 2010

CONZIP

NDA NDA022370

Sep 1, 2020

QDOLO

NDA NDA214044

Sources

References

[1]
ClinicalTrials.gov — 153 trial records for Tramadol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ultram drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tramadol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tramadol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214044). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Ultram. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Mu Opioid Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: WWim Janssens

Patent Landscape[6]

Patent Cliff

Sep 1, 2040

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11103452Sep 1, 2040

11752103Sep 1, 2040

Ultram

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q2 2027

Q4 2027

Trials by Indication[1]

Tramadol10 trials

Post Operative Pain7 trials

Hysteroscopy7 trials

Postoperative Analgesia6 trials

Analgesia4 trials

Analgesic4 trials

Cesarean Section3 trials

Post Spinal Anesthesia Shivering3 trials

Acute Postoperative Pain3 trials

Efficacy and Safety3 trials

Pain Management3 trials

Neuropathic Pain2 trials

Tonsillectomy2 trials

Laparoscopic Cholecystectomy2 trials

Osteoarthritis2 trials

Hip Fracture2 trials

Ibuprofen2 trials

Prevention2 trials

Pain Control2 trials

Opioid Withdrawal2 trials

Treatment2 trials

Abdominal Surgery2 trials

Total Knee Arthroplasty2 trials

Shoulder Arthroplasty2 trials

Menopausal Women2 trials

Bone Fracture1 trial

Mucositis1 trial

Vascular Function1 trial

ACL Reconstruction1 trial

Multimodal Analgesia1 trial

Spinal Anesthesia1 trial

Perioperative Pain Control1 trial

Hallux valgus1 trial

Adverse Effect1 trial

Breast Cancer1 trial

Infiltration1 trial

Intravenous1 trial

Rectus Sheath Block1 trial

Prostatectomy1 trial

Patient Preference1 trial

Celecoxib1 trial

Postoperative Pain Control1 trial

Pregabalin1 trial

Dental Implant1 trial

Buprenorphine1 trial

Thoracotomy1 trial

Abortion1 trial

Platelet Function1 trial

Sternotomy1 trial

Adenoma1 trial

Shoulder pain1 trial

Laparoscopic Cholecystectomy Surgery1 trial

Major Trauma1 trial

Sleep Apnea1 trial

Post-Traumatic Stress Disorder, PTSD1 trial

Opioid Addiction1 trial

Caesarean Section1 trial

Function1 trial

Metabolism1 trial

Postpartum Depression1 trial

Sinus Surgery1 trial

Appendicitis1 trial

Abdominal Cancer Surgery1 trial

Lidocaine Infusion1 trial

Muscle weakness1 trial

Dexmedetomidine1 trial

COVID-191 trial

Tolerance1 trial

Children1 trial

Acute Pancreatitis1 trial

Local Anesthesia1 trial