Treats overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and…. Sold as Botox, Botox Cosmetic. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for OnabotulinumtoxinA (sold as Botox, Botox Cosmetic), first approved Dec 9, 1991, with 24 new uses approved and 0 published complete response letters.
| EndoFLIP-Guided Initial Management of Esophagogastric Junction Outflow ObstructionEsophagogastric Junction Outflow Obstruction · Hospital Clinic of Barcelona | Not applicable | Not yet recruiting | Nov 10, 2026 |
| Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?Wrinkles and Rhytides · Project Skin MD | Phase 2 | Not yet recruiting | Nov 6, 2026 |
| Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.Acne, Acne Papulopustulosa · Cairo University | Phase 3 | Not yet recruiting | Nov 5, 2026 |
| Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic NeuropathyDiabetic Peripheral Neuropathy, Painful Diabetic Neuropathy · Assiut University | Phase 2 | Not yet recruiting | Oct 20, 2026 |
| Cleft Lip Scarring After BotoxCleft Lip, Cleft Lip Scar · Children's National Research Institute | Phase 2 | Recruiting | Oct 19, 2026 |
| MRI Study of OnabotulinumtoxinA (OnabotA) Effect on Jaw Muscle PainMasticatory Myofascial Pain Syndrome · Weill Medical College of Cornell University | Phase 2 | Not yet recruiting | Oct 16, 2026 |
| Can Adjunctive Oral Magnesium Supplementation Prolong the Effect of Botulinum Toxin Type A in Excessive Gingival Display?Magnesium, Botulinum Toxin Type A · Cairo University | Not applicable | Enrolling by invitation | Oct 14, 2026 |
| Decision Regret Following Yonsei-Point Botulinum Toxin for Gummy SmileExcessive Gingival Display · Cairo University | — | Not yet recruiting | Oct 14, 2026 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Dec 9, 1991 | Botox, Botox CosmeticBLA 103000 · New molecular entity | Allergan | 59 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Allergan