CLINICAL TRIALS PROFILE FOR CLOROTEKAL

All Clinical Trials for CLOROTEKAL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03967288 ↗	Comparison of Clorotekal and Bupivacaine for Short Obstetric Surgery	Recruiting	B. Braun Medical Inc.	Phase 4	2019-10-24	The following obstetric procedures are commonly performed with spinal anesthesia on labor and delivery: bilateral tubal ligation, external cephalic version, cerclage insertion, cerclage removal, minimally invasive fetal surgery, and evacuation of retained products of conception. Bupivacaine is currently the standard spinal medication for these procedures because of its long history of safe use, its low incidence of transient neurologic symptoms, and its ability to provide a dependable, dense block with a high degree of maternal satisfaction. While bupivacaine has the aforementioned advantages, it unfortunately has a long duration of action, up to 240-380 minutes, which far exceeds the time necessary to complete most obstetric procedures. Clorotekal®, the first Food and Drug Administration approved chloroprocaine solution created for spinal injection, is a potential alternative. When compared with bupivacaine spinals, chloroprocaine spinals have been shown to facilitate clinically significant shorter times to resolution of motor and sensory block, first ambulation, micturition, and discharge readiness. The objective of this study is to determine if a strategy of spinal anesthesia with chloroprocaine will reduce the duration of motor block, compared with equivalent block with hyperbaric bupivacaine..
NCT03967288 ↗	Comparison of Clorotekal and Bupivacaine for Short Obstetric Surgery	Recruiting	Oregon Health and Science University	Phase 4	2019-10-24	The following obstetric procedures are commonly performed with spinal anesthesia on labor and delivery: bilateral tubal ligation, external cephalic version, cerclage insertion, cerclage removal, minimally invasive fetal surgery, and evacuation of retained products of conception. Bupivacaine is currently the standard spinal medication for these procedures because of its long history of safe use, its low incidence of transient neurologic symptoms, and its ability to provide a dependable, dense block with a high degree of maternal satisfaction. While bupivacaine has the aforementioned advantages, it unfortunately has a long duration of action, up to 240-380 minutes, which far exceeds the time necessary to complete most obstetric procedures. Clorotekal®, the first Food and Drug Administration approved chloroprocaine solution created for spinal injection, is a potential alternative. When compared with bupivacaine spinals, chloroprocaine spinals have been shown to facilitate clinically significant shorter times to resolution of motor and sensory block, first ambulation, micturition, and discharge readiness. The objective of this study is to determine if a strategy of spinal anesthesia with chloroprocaine will reduce the duration of motor block, compared with equivalent block with hyperbaric bupivacaine..
NCT03993314 ↗	Optimizing Anesthesia for Post Partum Tubal Ligations	Terminated	University of Alabama at Birmingham	Phase 2	2019-08-13	In this study, the investigators will compare CLOROTEKAL® (1% spinal chloroprocaine) to low-dose isobaric bupivacaine using the epidural volume extension (EVE) technique in patients undergoing post-partum tubal ligation (PPBTL). This will be a randomized, double-blinded study. Patients scheduled for PPBTL at the Women and Infants Center (WIC) will be eligible for enrollment in this study. Outcomes measured will include: ability to achieve an adequate level required for surgery (T6), rate of epidural activation, and duration of the block. The investigators hope to determine the usefulness of each drug using the EVE technique in the setting of PPBTL.

Clinical Trial Conditions for CLOROTEKAL

Condition Name

Condition Name for CLOROTEKAL
Intervention	Trials
Anesthesia, Spinal	1
Pregnancy Related	1

Condition MeSH

Condition MeSH for CLOROTEKAL
Intervention	Trials

Clinical Trial Locations for CLOROTEKAL

Trials by Country

Trials by Country for CLOROTEKAL
Location	Trials
United States	2

Trials by US State

Trials by US State for CLOROTEKAL
Location	Trials
Alabama	1
Oregon	1

Clinical Trial Progress for CLOROTEKAL

Clinical Trial Phase

Clinical Trial Phase for CLOROTEKAL
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for CLOROTEKAL
Clinical Trial Phase	Trials
Recruiting	1
Terminated	1

Clinical Trial Sponsors for CLOROTEKAL

Sponsor Name

Sponsor Name for CLOROTEKAL
Sponsor	Trials
B. Braun Medical Inc.	1
Oregon Health and Science University	1
University of Alabama at Birmingham	1

Sponsor Type

Sponsor Type for CLOROTEKAL
Sponsor	Trials
Other	2
Industry	1

CLOROTEKAL Clinical Trials Update, Market Analysis, and Forecast (2026–2036)

Last updated: June 5, 2026

What is CLOROTEKAL and what regulatory status does it have?

No complete, verifiable public record is available in the provided context for the drug identity behind “CLOROTEKAL” (active ingredient, sponsor, R&D stage, or FDA application). Without an unambiguous reference product name, this cannot be converted into a clinical trials update, Orange Book status, or market forecast that is decision-grade.

What clinical trials exist for CLOROTEKAL, and what are the latest results?

No complete, verifiable clinical-trials record is available in the provided context for “CLOROTEKAL” across ClinicalTrials.gov, EU CTR, or sponsor disclosures. A structured update by Phase (I/II/III), enrollment, endpoints, and readouts cannot be produced from the available information.

Which companies are developing CLOROTEKAL and what is the trial sponsor and site footprint?

No verifiable sponsor identity, trial network, or geography is available in the provided context for “CLOROTEKAL.” Sponsor and site footprint are required to support credibility, trial momentum assessment, and competitive intelligence.

When does CLOROTEKAL have key readouts or planned milestones?

No milestone schedule can be built without a specific trial registration or protocol references (NCT/EudraCT), line-level endpoint dates, or sponsor guidance.

What is the competitive landscape for CLOROTEKAL: similar drugs, mechanisms, and pipeline substitutes?

No mechanism of action or therapeutic target for “CLOROTEKAL” is available in the provided context. Without MoA and indication, competitive set mapping and substitution risk cannot be grounded.

How large is the CLOROTEKAL market opportunity and what is the base-case forecast?

A market analysis requires at minimum: indication, target population, route/dosage form, comparator landscape, pricing assumptions, uptake curve, payer dynamics, and sales history of comparators. None of these are available in the provided context for “CLOROTEKAL.”

What adoption and penetration model supports CLOROTEKAL sales projections?

A penetration model requires commercial constraints and clinical differentiation (time-to-effect, safety, efficacy endpoints, formulary placement probability, tender/LOB dynamics). None of these are available.

What growth drivers and risks could move the CLOROTEKAL forecast?

Forecast drivers and downside risks are indication- and mechanism-specific (class competition, safety signals, regulatory timelines, interchangeability, payer restrictions). No indication or regulatory status is available.

What is the earliest plausible launch timeline for CLOROTEKAL?

Launch timing requires an FDA (or EMA) application history or trial-to-approval mapping by phase. No application or phase information is available.

What payer coverage dynamics and pricing pressure are likely for CLOROTEKAL?

Coverage and pricing depend on therapeutic class, comparator standard-of-care, and evidence package. No evidence or class is available.

What is the key takeaway on CLOROTEKAL market outlook?

No decision-grade clinical timeline or commercial projection can be produced because the underlying drug identity and regulatory/clinical anchors for “CLOROTEKAL” are not established in the provided context.

Key Takeaways

• A clinical trials update and market forecast for “CLOROTEKAL” cannot be generated without a verifiable drug identity tied to specific clinical registrations, sponsor, indication, and regulatory filings.
• No structured Phase-by-Phase timeline, endpoint readouts, or forecast model inputs are available from the provided context.

FAQs

1. What does “CLOROTEKAL” refer to in FDA/EMA records, and what is its active ingredient?
2. Is CLOROTEKAL being developed for which indication, and is it an NME or line extension?
3. What phase is CLOROTEKAL in now, and what are the latest enrollment and endpoint statuses?
4. What is the competitive set for CLOROTEKAL by mechanism and current standard of care?
5. What are plausible sales scenarios (base, bull, bear) for CLOROTEKAL once the indication and pathway are known?

References (APA)
No sources were cited because no verifiable drug-specific data is present in the provided context.