Cyclobenzaprine is named as an intervention in 2 current clinical trials in our USA and Canada registers. 1 is recruiting patients now. The most common phase is Phase 2. The lead sponsor is Tonix Pharmaceuticals, Inc. The most-studied condition is Major Depressive Episode (MDE).
Of the three regulators tracked here, the first to approve Cyclobenzaprine was the US, on 26 Aug 1977. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Protections still running for marketed products containing Cyclobenzaprine, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
Reproduced from the FDA Orange Book and Purple Book (checked 28 Sep 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
NCT07621237 · ClinicalTrials.gov ↗ · Major Depressive Episode (MDE), Major Depressive Disorder (MDD), Depression
|
Phase 2 | Recruiting | Tonix Pharmaceuticals, Inc | USA |
|
A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine Hydrochloride Sublingual Tablet) In Non-Elderly Versus Elderly Participants
NCT07413367 · ClinicalTrials.gov ↗ · Pharmakokinetic, Open Label, Phase 1
|
Phase 1 | Active, closed | Tonix Pharmaceuticals, Inc | Canada |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
| Lead sponsor | Trials |
|---|---|
| Tonix Pharmaceuticals, Inc | 2 |
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in USA | 1 | 1 |
| Clinical trials in Canada | 1 | 0 |
A trial with sites in more than one country appears in each of those registers.
2 current trials in our USA and Canada registers name Cyclobenzaprine (also registered as TNX-102 SL) as a drug or biological intervention, as of the registry sync on 1 October 2026. Completed and withdrawn studies are not counted.
Yes. 1 of the 2 trials is recruiting: 1 with sites in USA. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
The lead sponsor is Tonix Pharmaceuticals, Inc. The number in brackets is how many trials each organisation leads.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Cyclobenzaprine works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Cyclobenzaprine works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Cyclobenzaprine (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 1 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.