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Benzidamine (BENZYDAMINE)
Benzidamine (generic name: BENZYDAMINE) is a benzydamine drug. It is currently in Phase 3 development for Pain.
Benzidamine works by activating soluble guanylate cyclase, an enzyme that produces cyclic guanosine monophosphate (cGMP), leading to pain relief.
Benzidamine, also known as benzydamine, is a small molecule drug that targets soluble guanylate cyclase. It is classified as a benzydamine and is used to treat pain. The commercial status of benzidamine is unknown, and it is not FDA-approved. Key safety considerations include its half-life of 8.1 hours and bioavailability of 87%. Further information on its generic status and patent status is not available.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | BENZYDAMINE |
|---|---|
| Drug class | benzydamine |
| Target | Soluble guanylate cyclase |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 3 |
Mechanism of action
Imagine your body has a messaging system that helps control pain. Soluble guanylate cyclase is a key part of this system, and when it's activated, it sends a signal to reduce pain. Benzidamine helps activate this enzyme, which can lead to pain relief.
Approved indications
- Pain
Common side effects
- Macular degeneration
- Neutropenic sepsis
- Mouth ulceration
- Skin candida
- Vaginal flatulence
- Chronic sinusitis
- Mucosal inflammation
- Hypomagnesaemia
- Constipation
- Paraesthesia oral
- Female genital tract fistula
- Procedural pain
Key clinical trials
- The Aim of This Study is to Compare the Effects of Two Different Topical Agents (KLOROBEN® and KLORHEX PLUS®) Used in the Surgical Extraction of Mandibular Bilateral Mesioangular Impacted Third Molars on Postoperative Pain, Edema, and Trismus. (NA)
- Benzydamine for Radiation-Induced Oral Mucositis in Patients Receiving High-Dose Radiotherapy (PHASE4)
- The Effect of Supplementary Foods Containing Trypsin, Chymotrypsin and Serratia Peptidase on Healing After Impacted Wisdom Tooth Surgery (NA)
- A Study on Sumac Mouth Rinse for Treating Recurrent Aphthous Stomatitis (NA)
- Palatability Study of Five Formulations of Benzydamine HCl Lozenges (PHASE1)
- A Prospective Study on the Therapeutic Outcomes of Mebo and Tantum Verde in Patients With Oral Mucositis (PHASE3)
- N Acetylcystene in Treatment of Radiotherapy Induced Oral Mucositis in Oral Cancer Patients (NA)
- Study to Evaluate the Efficacy and Safety of Different Doses of Graminidin With Anesthetic, a Metered Dose Topical Spray, in the Treatment of Acute Infectious and Inflammatory Pharyngeal Diseases Compared With Drug Septolete Total, Lozenges (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Benzidamine CI brief — competitive landscape report
- Benzidamine updates RSS · CI watch RSS
Frequently asked questions about Benzidamine
What is Benzidamine?
How does Benzidamine work?
What is Benzidamine used for?
What is the generic name of Benzidamine?
What drug class is Benzidamine in?
What development phase is Benzidamine in?
What are the side effects of Benzidamine?
What does Benzidamine target?
Related
- Drug class: All benzydamine drugs
- Target: All drugs targeting Soluble guanylate cyclase
- Therapeutic area: All drugs in Pain
- Indication: Drugs for Pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing