Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TNX-201 · 2 trials · 2 indications
Number of subjects pain free at 2 hours post-dose (Pain assessed by 4-point NRS, VAS, and binary yes/no question). 4-point NRS grades: 0=none, 1=mild, 2=moderate, 3=severe; "pain-free" defined as score = 0. VAS: 0-100 scale, anchored by verbal anchors of No Pain (0) vs. Worst Imaginable Headache Pain (100). "Pain-free" was defined as a score \<= 5
| Arm | Type | Description |
|---|---|---|
| TNX-201 | EXPERIMENTAL | 4 X 35 mg capsules to be taken when qualifying tension-type headache occurs |
| Placebo | PLACEBO_COMPARATOR | 4 X placebo capsules to be taken when qualifying tension-type headache occurs |
| TNX-201 35 mg | EXPERIMENTAL | Drug: TNX-201 35 mg |
| TNX-201 70 mg | EXPERIMENTAL | Drug: TNX-201 70 mg |
| TNX-201 140 mg | EXPERIMENTAL | Drug: TNX-201 140 mg |
| Racemic isometheptene 70 mg | ACTIVE_COMPARATOR | Comparator: Racemic Isometheptene 70 mg |
| Name | Type | Description |
|---|---|---|
| TNX-201 | DRUG | TNX-201 capsule |
| Placebo | DRUG | Placebo capsule |
| TNX-201 35 mg | DRUG | Drug: TNX-201 35 mg |
| TNX-201 70 mg | DRUG | Drug: TNX-201 70 mg |
| TNX-201 140 mg | DRUG | Drug: TNX-201 140 mg |
| Racemic isometheptene 70 mg | DRUG | Active Comparator: Racemic isometheptene 70 mg |
Inclusion Criteria: 1. Capable of reading and understanding English and able to provide written informed consent to participate. 2. Male or female adults ≥ 18 and \< 65 years of age at the time of Visit 1. 3. Body mass index (BMI) ≥ 18.5 and ≤ 45.0. 4. Greater than 1 year history of episodic tensio...
TNX-201 is an investigational small molecule being developed by Tonix Pharmaceuticals for the treatment of tension-type headache. It has been studied in healthy volunteers and in patients with tension-type headache. The drug is currently in clinical development and is not approved by the FDA.
TNX-201 is being developed by Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TNXP. The company has conducted clinical trials to evaluate the safety and efficacy of TNX-201 for tension-type headache.
TNX-201 has completed a Phase 1 trial in healthy volunteers and a Phase 2 trial in patients with tension-type headache. Both trials are completed, and the drug is currently in clinical development. It is not approved by the FDA.
TNX-201 has been studied in two completed clinical trials. NCT02290379 was a Phase 1 single ascending dose safety study in 27 healthy volunteers. NCT02423408 was a Phase 2 safety and efficacy study in 165 patients with tension-type headache in the United States.
TNX-201 is the primary name for this investigational drug. No alternative names have been reported for TNX-201 in clinical trial registries. It is a small molecule being studied for the treatment of tension-type headache.