Approval Probability
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Adjusted LOA
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Thiocolchicoside+Ketoprofen · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | 1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d |
| 2 | ACTIVE_COMPARATOR | 2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d |
| Name | Type | Description |
|---|---|---|
| Thiocolchicoside+Ketoprofen | DRUG | 1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d |
| Thiocolchicoside | DRUG | 2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d |
List of Inclusion and Exclusion criteria : Inclusion Criteria: * Non specific low back pain with an acute episode of recent onset (\<48 hours) defined by average pain within the last 24 hours equal or more than 50 mm on the Visual Analogue Scale (VAS) * Low back pain of diagnosis category 1 (low b...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Hinge Health, Inc. Class A | HNGE | 1 | N/A | Undisclosed |
| Stryker Corporation | SYK | 1 | - | Undisclosed |
| Boston Scientific Corporation | BSX | 1 | N/A | Undisclosed |
| Aclarion, Inc. | ACON | 1 | - | Undisclosed |
| United Therapeutics Corporation | UTHR | 1 | N/A | Undisclosed |
| eHealth, Inc. | EHTH | 1 | N/A | Undisclosed |
Thiocolchicoside+Ketoprofen is a small molecule combination being developed by Sanofi for the treatment of low back pain. It is currently in Phase 3 clinical development, meaning it is investigational and has not yet been approved by regulatory authorities. The combination is being studied in patients suffering from acute non-specific low back pain.
Thiocolchicoside+Ketoprofen combines a muscle relaxant (thiocolchicoside) with a nonsteroidal anti-inflammatory drug (ketoprofen). Thiocolchicoside acts on the central nervous system to relieve muscle spasms, while ketoprofen reduces inflammation and pain. Together, they aim to address both the muscular and inflammatory components of low back pain.
Thiocolchicoside+Ketoprofen is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this combination therapy for low back pain.
Thiocolchicoside+Ketoprofen is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 3 trial has been completed, and the results will determine whether the drug can proceed to regulatory submission.
Thiocolchicoside+Ketoprofen has one completed Phase 3 trial, identified as NCT00679146. This randomized, double-blind, active-controlled study enrolled 334 patients with acute non-specific low back pain across Brazil, Colombia, Egypt, Guatemala, Mexico, and Venezuela. The trial compared the combination to thiocolchicoside alone, administered twice daily for 7 days.
Thiocolchicoside+Ketoprofen is a fixed-dose combination of two active ingredients: thiocolchicoside and ketoprofen. It is not the same as thiocolchicoside alone, which is a single-ingredient muscle relaxant. The combination is being studied to determine if adding ketoprofen provides additional pain relief compared to thiocolchicoside monotherapy.