NDAORALSOLUTION
Approved
Sep 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
QDOLO (tramadol hydrochloride) by Athena Bioscience is tramadol, an opioid agonist and inhibitor of norepinephrine and serotonin re- uptake. First approved in 2020.
Drug data last refreshed 21h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QDOLO is an oral solution formulation of tramadol hydrochloride, a centrally acting analgesic approved in 2020. It works through dual mechanisms: μ-opioid receptor agonism and inhibition of norepinephrine and serotonin reuptake, with analgesic onset within one hour and peak effect at 2–3 hours. The active metabolite M1 is significantly more potent than the parent compound, contributing substantially to analgesia in humans.
Peak13.9 years to LOE
QDOLO is in peak lifecycle phase with 14 years of patent protection remaining, suggesting stable commercial operations and moderate team size focused on maintenance and optimization.
Mechanism of Action
tramadol, an opioid agonist and inhibitor of norepinephrine and serotonin re- uptake. Although the mode of action is not completely understood, the analgesic effect of tramadol is believed to be due to both binding to μ-opioid receptors and weak inhibition of re-uptake of norepinephrine and…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain
Started Sep 2020
538 enrolled
Low Back Pain
Bioequivalence Study of Tramadol Hydrochloride /Paracetamol Tablets Versus Ultracet Tablets
Started Mar 2019
60 enrolled
Healthy
Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar
Started Apr 2016
654 enrolled
Acute Pain
Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants
Started Dec 2014
68 enrolled
Healthy
A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers
Started Aug 2013
30 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.