Last reviewed · How we verify
Chloroprocaine 3%
Chloroprocaine 3% is a Local anesthetic (ester) Small molecule drug developed by Sintetica SA. It is currently in Phase 3 development for Local anesthesia for infiltration, nerve block, and epidural anesthesia. Also known as: Arm 1.
Chloroprocaine is a local anesthetic that blocks sodium channels in nerve cell membranes, preventing the initiation and propagation of nerve impulses.
Chloroprocaine is a local anesthetic that blocks sodium channels in nerve cell membranes, preventing the initiation and propagation of nerve impulses. Used for Local anesthesia for infiltration, nerve block, and epidural anesthesia.
-
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 | Chloroprocaine 3% |
|---|---|
| Also known as | Arm 1 |
| Sponsor | Sintetica SA |
| Drug class | Local anesthetic (ester) |
| Target | Voltage-gated sodium channels |
| Modality | Small molecule |
| Therapeutic area | Anesthesia |
| Phase | Phase 3 |
Mechanism of action
As an ester-type local anesthetic, chloroprocaine reversibly inhibits sodium influx through voltage-gated sodium channels in nerve fibers, thereby preventing depolarization and action potential generation. This results in loss of sensation in the infiltrated tissue. Chloroprocaine is rapidly metabolized by plasma pseudocholinesterase, giving it a short duration of action.
Approved indications
- Local anesthesia for infiltration, nerve block, and epidural anesthesia
Common side effects
- Transient paresthesia
- Headache
- Back pain
- Hypotension
- Allergic reactions (rare)
Key clinical trials
- Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population (PHASE3)
- Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal Injections (PHASE4)
- The Effects of Low Viscosity Chloroprocaine Ophthalmic Gel 3% on the Bactericidal Action of Povidone-Iodine (PHASE4)
- Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery (EARLY_PHASE1)
- Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section (PHASE3)
- Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture (PHASE4)
- Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification. (PHASE3)
- Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine (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:
- Chloroprocaine 3% CI brief — competitive landscape report
- Chloroprocaine 3% updates RSS · CI watch RSS
- Sintetica SA portfolio CI
Frequently asked questions about Chloroprocaine 3%
What is Chloroprocaine 3%?
How does Chloroprocaine 3% work?
What is Chloroprocaine 3% used for?
Who makes Chloroprocaine 3%?
Is Chloroprocaine 3% also known as anything else?
What drug class is Chloroprocaine 3% in?
What development phase is Chloroprocaine 3% in?
What are the side effects of Chloroprocaine 3%?
What does Chloroprocaine 3% target?
Related
- Drug class: All Local anesthetic (ester) drugs
- Target: All drugs targeting Voltage-gated sodium channels
- Manufacturer: Sintetica SA — full pipeline
- Therapeutic area: All drugs in Anesthesia
- Indication: Drugs for Local anesthesia for infiltration, nerve block, and epidural anesthesia
- Also known as: Arm 1
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing