Last reviewed · How we verify
Sotalex
Sotalex is a Small molecule drug developed by Pharmtechnology LLC. It is currently in Phase 1 development. Also known as: the reference product.
Sotalol is a small molecule used in the treatment of various conditions, including Atrial Fibrillation, Ventricular Tachycardia, and Coronary Artery Disease. It has been studied in clinical trials alongside other antiarrhythmic drugs such as Amiodarone and Propafenone.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Sotalex |
|---|---|
| Also known as | the reference product |
| Sponsor | Pharmtechnology LLC |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation (NA)
- Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex ®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Conditions (PHASE1)
- Trial Comparing Ablation With Medical Therapy in Patients With Ventricular Tachycardia (PHASE3)
- Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator (NA)
- Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation (PHASE4)
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:
- Sotalex CI brief — competitive landscape report
- Sotalex updates RSS · CI watch RSS
- Pharmtechnology LLC portfolio CI
Frequently asked questions about Sotalex
What is Sotalex?
Who makes Sotalex?
Is Sotalex also known as anything else?
What development phase is Sotalex in?
Related
- Manufacturer: Pharmtechnology LLC — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: the reference product
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing