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Ecclock (SOFPIRONIUM BROMIDE)
Ecclock works by blocking the muscarinic acetylcholine receptor M3, which reduces sweat gland activity.
Ecclock (Sofpironium bromide) is a small molecule developed by Kaken Pharmaceutical and currently owned by Botanix Sb. It targets the muscarinic acetylcholine receptor M3, which is involved in sweat gland function. Ecclock is approved for the treatment of hyperhidrosis, a condition characterized by excessive sweating. The commercial status of Ecclock is patented, with no generic manufacturers available. Key safety considerations include its mechanism of action, which may have implications for patients with certain medical conditions.
At a glance
| Generic name | SOFPIRONIUM BROMIDE |
|---|---|
| Sponsor | Kaken Pharmaceutical |
| Target | Muscarinic acetylcholine receptor M3 |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2024 |
Mechanism of action
Imagine your nerves sending signals to your sweat glands to produce sweat. Ecclock blocks these signals, so your sweat glands don't get the message to produce as much sweat. This helps to reduce excessive sweating.
Approved indications
- Hyperhidrosis
Common side effects
- Vision blurred
- Dry mouth
- Application site pruritus
- Application site pain
- Application site dermatitis
- Application site erythema
- Application site irritation
- Mydriasis
- Application site rash
- Upper respiratory tract infection
- Dry eye
- Urinary retention
Key clinical trials
- Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) (PHASE3)
- Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) (PHASE3)
- A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis (PHASE3)
- A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis (PHASE2)
- A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis (PHASE2)
- A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ecclock CI brief — competitive landscape report
- Ecclock updates RSS · CI watch RSS
- Kaken Pharmaceutical portfolio CI