Ultram

(Tramadol hydrochloride)

ApprovedSmall molecule

Tramadol is used to treat moderate to moderately severe pain in adults. It works by changing how the body senses and responds to pain.[2] Ultram is currently approved and in use across 10 indications[4].[1]

Ultram is one of 169 small molecule programs targeting Chronic pain. It is currently in Approved.

Indications

Total Trials

Active Trials

168

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Chronic PainUnknown

Drug DependenceUnknown

SatisfactionCompleted

Back PainActive, not recruiting

Quadratus Lumborum BlockCompleted

Local InfiltrationCompleted

HysterectomyCompleted

FibromyalgiaCompleted

Post Operative Sore ThroatRecruiting

Analgesic EfficacyRecruiting

Chronic PainPreclinical

Unknown

Drug DependencePreclinical

Unknown

SatisfactionPreclinical

Completed

Back PainApproved

Active, not recruiting

Quadratus Lumborum BlockPreclinical

Completed

Local InfiltrationPreclinical

Completed

HysterectomyApproved

Completed

FibromyalgiaApproved

Completed

Post Operative Sore ThroatApproved

Recruiting

Analgesic EfficacyApproved

Recruiting

Competition

Competitive Landscape

77 competitors in Chronic Pain

#DrugCompanyPhaseTrials

Voltaren

Novartis

Approved

1 2

MS Contin

HHikma Pharmaceuticals LLC

Approved

4 3

Suboxone

IIndivior Inc.

Approved

3 4

Ultram

WWim Janssens

Approved

1 5

Pitocin

RRetrophin

Approved

1 6

Marcaine

IInnocoll

Approved

1 7

Tylenol

KKenvue Brands

Approved

1 8

Sufenta

LLeaf Vertical Inc.

Approved

1 9

Norpramin

VValidus Pharmaceuticals

Approved

1 10

Mirapex

Boehringer Ingelheim

Approved

—

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

Timeline

Expected Milestones

Q3 2026

Post-ApprovalRecruiting

Analgesic Efficacy

NCT07440069

Clinical

Trials by Indication[1]

Interaction3 trials

Administration of Tramadol and Ketorolac Separately and Simultaneously to Assess a Potential Pharmacokinetic Interaction

Completed·GGrünenthal GmbH·Phase 1·NCT03767036·30 enrolled

Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac

Completed·GGrünenthal GmbH·Phase 1·NCT03766984·36 enrolled

Drug-Drug Interaction Study of "CG100650" in Healthy Volunteers

Completed·CCrystalGenomics, Inc.·Phase 1·NCT03775629·41 enrolled

Premature Ejaculation2 trials

Combined On-demand Sildenafil Citrate and Tramadol Hydrochloride for Treatment of Premature Ejaculation

Unknown status·—·Phase 4·NCT05183334·160 enrolled

Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation

Terminated·BBausch Health Americas, Inc.·Phase 3·NCT00983736·1,050 enrolled

Quadratus Lumborum Block2 trials

Quadratus Lumborum Block in Pediatric Patients

Completed·—·N/A·NCT03693222·40 enrolled

Transversus Abdominis Plane Block and Quadratus Lumborum Block in Pediatric Patients

Completed·—·N/A·NCT04209478·40 enrolled

Tramadol2 trials

Study of Two Tramadol Contramid® OAD 300 mg Controlled-Release Tablets From Two Different Manufacturing Sites Following a 300 mg Dose in Healthy Subjects Under Fasting and Fed Conditions

Completed·LLabopharm Inc.·Phase 1·NCT00834912·36 enrolled

Use of Tramadol Intraligamentary Injections

Completed·JJamia Millia Islamia·N/A·NCT05538052·105 enrolled

Efficacy and Safety1 trial

A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment

Completed· Haisco Pharmaceutical Group Co., Ltd. logo

Haisco Pharmaceutical Group Co., Ltd.·Phase 3·NCT05390905·387 enrolled

22 more indications

Hysterectomy1 trial

Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy

Completed·NNanjing Medical University·Phase 4·NCT00510666·841 enrolled

Severe Pain1 trial

Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain

Completed· Menarini logo

Menarini·Phase 2·NCT01307020·745 enrolled

Low back pain1 trial

Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain

Completed·MMenarini International Operations Luxembourg SA·Phase 4·NCT05170841·538 enrolled

Back pain1 trial

Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00290901·754 enrolled

Opioid1 trial

Opioid Induced Gait Variability

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

Satisfaction1 trial

To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine

Completed·HHaEmek Medical Center, Israel·N/A·NCT02440399·200 enrolled

Analgesia1 trial

Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia

Unknown status·—·Phase 4·NCT03694873·200 enrolled

Erector Spinae Block1 trial

Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients

Completed·—·Phase 3·NCT04613830·60 enrolled

Thoracic Surgery1 trial

Comparison of Tramadol, Pethidine and Morphine in the Treatment of Pain After Thoracic Surgery

Unknown status·—·Phase 4·NCT06172920·45 enrolled

Pain1 trial

A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00737048·328 enrolled

Cancer Pain1 trial

Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain

Unknown status·—·Phase 2/3·NCT04589494·15 enrolled

Analgesic Efficacy1 trial

Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor

Recruiting·UUniversidad Nacional Autonoma de Honduras·Phase 4·NCT07440069·300 enrolled

Acute Postoperative Pain1 trial

Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach.

Completed·KKAT General Hospital·Phase 2·NCT04178109·226 enrolled

Postoperative Pain Management1 trial

Intraoperative Use of Dexketoprofen Trometamol, Pethidine Hcl, Tramadol Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication

Unknown status·KKavaklıdere Umut Hospital·Phase 4·NCT01558622·72 enrolled

Local Infiltration1 trial

Dexamethasone Versus Local Infiltration Technique for Tonsillectomy in Children

Completed·MMakassed General Hospital·N/A·NCT02355678·129 enrolled

Labor Analgesia1 trial

Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial

Unknown status·MMaulana Azad Medical College·Phase 2·NCT02999594·86 enrolled

Chronic pain1 trial

Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain

Withdrawn·EEMS·Phase 2·NCT05125978

Post Operative Sore Throat1 trial

Effect of Tramadol on Postoperative Sore Throat After General Anesthesia

Recruiting·—·Phase 4·NCT04991493·168 enrolled

Fibromyalgia1 trial

An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain

Completed·JJohnson & Johnson Taiwan Ltd·Phase 4·NCT00766675·80 enrolled

Intravenous1 trial

Intravenous Paracetamol Versus Intramuscular Tramadol in Shortening the Duration of Labour.

Completed·FFederal Teaching Hospital Abakaliki·N/A·NCT07394491·189 enrolled

Nerve Block1 trial

Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis

Completed·MMedical University of Warsaw·Phase 4·NCT03477851·40 enrolled

Post Operative Pain1 trial

Paracetamol Plus Tramadol Versus Fentanyl as Pre-emptive Analgesia for Enhanced Recovery After Day-Case Surgeries: A Randomised Controlled Trial

Completed·ZZagazig University·Approved·NCT05990686·102 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 — 32 trial records for Tramadol hydrochloride. 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 hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tramadol hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214044). U.S. Food & Drug Administration.
[6]
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

Ultram

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Trials by Indication[1]

Interaction3 trials

Premature Ejaculation2 trials

Quadratus Lumborum Block2 trials

Tramadol2 trials

Efficacy and Safety1 trial

Hysterectomy1 trial

Severe Pain1 trial

Low back pain1 trial

Back pain1 trial

Opioid1 trial

Satisfaction1 trial

Analgesia1 trial

Erector Spinae Block1 trial

Thoracic Surgery1 trial

Pain1 trial

Cancer Pain1 trial

Analgesic Efficacy1 trial

Acute Postoperative Pain1 trial

Postoperative Pain Management1 trial

Local Infiltration1 trial

Labor Analgesia1 trial

Chronic pain1 trial

Post Operative Sore Throat1 trial

Fibromyalgia1 trial

Intravenous1 trial

Nerve Block1 trial

Post Operative Pain1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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