CLINICAL TRIALS PROFILE FOR SUCCINYLCHOLINE CHLORIDE

All Clinical Trials for succinylcholine chloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00235976 ↗	The Efficacy and Safety of Gantacurium Chloride for Injection in Tracheal Intubation in Healthy Adult Patients Undergoing Surgery Under General Anesthesia	Completed	Avera Pharmaceuticals	Phase 1/Phase 2	2005-05-01	This is a multicenter, randomized, controlled, observer-blinded, dose-response study to evaluate the efficacy in tracheal intubation and safety of gantacurium chloride for injection in healthy adult patients undergoing surgery with general anesthesia. Gantacurium chloride for injection (previously referred to as AV430A) is a new, investigational non-depolarizing ultra-short acting neuromuscular blocking agent (NMB). Preliminary results in animals and healthy human subjects (Phase 1 studies in adult volunteers) suggest that gantacurium chloride for injection may provide a useful adjunct to general anesthesia by permitting rapid intubation. This Phase 2 study will provide more definitive information on the ultra-short acting profile of the compound by determining the quality of intubation in patients, at 60 seconds, as assessed by a blinded intubator. In addition, the safety of the compound will be assessed. In this study, the efficacy and safety of gantacurium chloride for injection will also be compared to a reference drug, succinylcholine, and to placebo. The primary objective of this study is to determine the dose-response relationship of gantacurium chloride for injection on tracheal intubation conditions after a single rapid bolus intravenous (i.v.) dose as a component of a propofol/opioid induction-intubation sequence and to assess the safety profile of this compound.
NCT02072135 ↗	Exparel and Ankle Surgery	Completed	Rutgers, The State University of New Jersey	N/A	2014-02-01	This study involves a drug called Exparel that has been approved by the US Food and Drug Administration (FDA), for application directly to wound sites. EXPAREL® is a long acting pain reliever. It is being given in this study to see if it provides safe and effective pain relief after ankle surgery. Because it is a long acting drug, it may lessen pain relief for as much as 72 hours after surgery. EXPAREL® has not been approved by the FDA for administration by popliteal block, which is the method the study doctors will use to give the patients the drug. Giving the drug by popliteal block involves inserting a small tube in to the back of the knee to deliver the drug. The study doctors wish to determine if patients undergoing ankle surgery and receiving this drug have less pain and less need for narcotic medication.
NCT06709066 ↗	Muscle Relaxant Effect and Safety of Mivacurium Chloride and Succinylcholine for Bronchoscopy	NOT_YET_RECRUITING	Peng Liang	NA	2024-11-20	The goal of this clinical trial is to evaluate whether mivacurium chloride and succinylcholine can provide effective and safe muscle relaxation in adult patients aged 18-60 years undergoing bronchoscopy who require muscle relaxants during anesthesia. The main questions it aims to answer are: * Is the recovery of spontaneous breathing within 15 minutes after drug discontinuation with mivacurium chloride non-inferior to succinylcholine? * How do mivacurium chloride and succinylcholine compare in terms of intraoperative hemodynamics and post-operative recovery and comfort? Researchers will compare the mivacurium chloride group and the succinylcholine group to observe if mivacurium chloride can provide similar or better recovery effects compared to succinylcholine. Participants will: * Receive either mivacurium chloride (0.14 mg/kg induction bolus + 0.5 mg/kg/h maintenance infusion) or succinylcholine (1 mg/kg induction bolus + 5 mg/kg/h maintenance infusion) as a muscle relaxant during bronchoscopy. * Have their vital signs, including blood pressure, oxygen saturation, and heart rate, monitored at multiple time points during the procedure. * Be assessed post-procedure for spontaneous breathing recovery, consciousness recovery, and time to laryngeal mask airway (LMA) removal, as well as overall comfort and satisfaction.

Clinical Trial Conditions for succinylcholine chloride

Condition Name

Condition Name for succinylcholine chloride
Intervention	Trials
Healthy	1
Muscle Relaxants	1
Anesthesia	1
Ankle Fracture	1

Condition MeSH

Condition MeSH for succinylcholine chloride
Intervention	Trials
Muscle Hypotonia	1
Fractures, Bone	1
Ankle Fractures	1

Clinical Trial Locations for succinylcholine chloride

Trials by Country

Trials by Country for succinylcholine chloride
Location	Trials
United States	1
Germany	1

Trials by US State

Trials by US State for succinylcholine chloride
Location	Trials
New Jersey	1

Clinical Trial Progress for succinylcholine chloride

Clinical Trial Phase

Clinical Trial Phase for succinylcholine chloride
Clinical Trial Phase	Trials
Phase 1/Phase 2	1
NA	1
N/A	1

Clinical Trial Status

Clinical Trial Status for succinylcholine chloride
Clinical Trial Phase	Trials
Completed	2
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for succinylcholine chloride

Sponsor Name

Sponsor Name for succinylcholine chloride
Sponsor	Trials
Avera Pharmaceuticals	1
Rutgers, The State University of New Jersey	1
Peng Liang	1

Sponsor Type

Sponsor Type for succinylcholine chloride
Sponsor	Trials
Other	2
Industry	1

Last updated: May 21, 2026

Succinylcholline Chloride Clinical Trials Update, Market Analysis & Launch/Exclusivity Projection

Executive summary. Public clinical-trials data and FDA brand-level regulatory exclusivity detail are not available in a way that supports a complete, decision-grade update for succinylcholine chloride specifically. Without verifiable, drug-specific trial status (NCT IDs, phases, endpoints, recruiting status, completion dates) and current regulatory market/access data that ties directly to “succinylcholline chloride” (spelling variant) at product-strength, manufacturer, and FDA listing level, an accurate market forecast or exclusivity projection cannot be produced.

What clinical trials involve succinylcholine chloride (NCTs, phase, and status)?

No drug-specific clinical-trials update can be compiled from the information provided. A decision-grade trials map requires named trials and verified status fields (recruiting/not yet recruiting/active/not recruiting/completed/terminated), plus at least: study design (randomization/blinding), comparator (e.g., rocuronium), dosing regimen, and primary endpoints (e.g., intubating conditions, time to onset, durability, incidence of adverse events such as bradycardia, hyperkalemia, malignant hyperthermia association).

Which study endpoints are typically evaluated for succinylcholine chloride?

Common endpoints in neuromuscular-blocker research include:

• Time to onset of neuromuscular block
• Time to peak effect
• Time to clinically relevant recovery
• Intubating conditions scores
• Incidence of adverse events (bradycardia, arrhythmia, muscle fasciculations, increases in serum potassium)

No verified trials set is available here to anchor an update.

How big is the succinylcholine chloride market and what is the near-term demand outlook?

A market analysis needs current segmenting and tie-in to US/EU availability through specific FDA product listings (ANDA/505(b)(2)/NDA), unit pricing ranges by strength, and utilization patterns (operating rooms, emergency medicine, anesthesia induction, rapid sequence intubation). That dataset is not present in the input.

What drives demand for succinylcholine chloride in anesthesia and emergency care?

Key drivers usually include:

• Surgical case volume and anesthesia utilization
• Emergency airway management protocols
• Guideline adherence and formulary selection
• Competition from alternatives (notably rocuronium, vecuronium) and practice patterns

A projection requires current market sizing and observable trends, which are not available here.

When does succinylcholine chloride lose exclusivity in the US (Orange Book, patents, exclusivity windows)?

A US exclusivity and patent-expiration projection requires Orange Book patent and exclusivity records tied to labeled products (listed drug, applicant/holder, patents with expiration dates, exclusivity type such as marketing exclusivity and pediatric exclusivity where applicable). No Orange Book status or patent list is provided.

What patents protect succinylcholine chloride products (formulation, method-of-use, packaging)?

Succinylcholine chloride is commonly marketed as an established generic; any remaining patent protection is often product-specific (e.g., formulation stability/sterility claims, manufacturing methods, container/closure, or specific dosing regimens). Without an Orange Book record set, an estate strength assessment is not supportable.

What patent estate covers succinylcholine chloride and how strong is it?

A patent estate map needs:

• Patent numbers, assignees, filing/grant dates, claim scope summaries, and legal status (expiration, terminal disclaimers, assignments).
• For litigated drugs: court docket outcomes, settlement triggers, and whether Paragraph IV certifications were filed.

No patent list or litigation record is provided.

Are there Paragraph IV challenges or ANDA litigation for succinylcholine chloride?

ANDA litigation analysis requires:

• FDA Paragraph IV notices (via FDA “Drug Patents and Exclusivity” and litigation dockets)
• Case captions, courts, filing dates, first amendment dates, and outcomes (dismissal, settlement, consent judgment)
• Launch “carve-out” details where relevant

No litigation dataset is available here.

How does succinylcholine chloride compare with rocuronium or other neuromuscular blockers on time-to-onset and recovery?

A comparative analysis should quantify:

• Onset time and intubating condition windows
• Recovery duration and reversal options
• Safety signals (hyperkalemia risk profiles, bradycardia rate)
• Real-world usage by indication (RSI vs elective anesthesia)

No comparative trial or guideline evidence is provided in the input to support a factual, cited comparison.

What formulations are protected for succinylcholine chloride (strengths, concentrations, lyophilized vs solution)?

Formulation/IP assessment requires product-level details:

• Strengths (e.g., mg/mL) and dosage forms (solution for injection)
• Container-closure system claims
• Stability and sterile manufacturing process patents
• Any pediatric dosing/formulation claims

No labeled product list or patent-to-formulation mapping is available.

What FDA regulatory status applies to succinylcholine chloride (505(b)(2), ANDA, listed drug, labeling)?

Regulatory status requires:

• FDA “Orange Book” listed drug entries and application numbers
• Application type per manufacturer
• Current labeling (indications, dosage, warnings)
• Any shortages or supply continuity statements

These records are not available in the input.

What generic entry risks exist for succinylcholine chloride (manufacturing/IP barriers, sterile fill-finish)?

A generic entry risk profile needs:

• Patent barriers (if any) and manufacturing method claims
• Data exclusivity constraints
• Sterile manufacturing capacity constraints and quality history
• FDA regulatory and inspection risk factors

No IP or manufacturing evidence is provided.

Key Takeaways

• A complete clinical-trials update for succinylcholine chloride cannot be produced without verified, drug-specific trial records (NCTs and status).
• A market analysis and forecast cannot be produced without current, product-tied regulatory and commercial inputs (FDA listing, unit economics, utilization trends).
• A US exclusivity and patent-expiration projection cannot be produced without Orange Book patent and exclusivity records tied to specific succinylcholine chloride listed drugs.

FAQs

1. What are the most common clinical outcomes used to evaluate succinylcholine chloride in anesthesia trials?
2. How do rocuronium and succinylcholine chloride compare for time-to-onset in rapid sequence intubation?
3. Which FDA application types (NDA vs ANDA vs 505(b)(2)) typically govern succinylcholine chloride products in the US?
4. What types of patents are most likely to remain after initial market entry for established IV neuromuscular blockers?
5. What supply and sterile manufacturing factors most affect availability of succinylcholine chloride injectable products?

References

No sources were cited because no drug-specific trial, Orange Book, litigation, or market/regulatory records were provided in the prompt.