CLINICAL TRIALS PROFILE FOR ARDUAN

All Clinical Trials for ARDUAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT07044180 ↗	Reversal of Pipecuronium-induced Neuromuscular Blockade With Sugammadex During Propofol Anesthesia	ACTIVE_NOT_RECRUITING	Tamas Vegh, MD	PHASE4	2025-06-26	Safety during modern practice of anaesthesia is of great concern. Patients admitted daily for surgical procedures undergoing general anaesthesia for different types of operations are exposed to different risks, starting from the anaesthesia and ending with the surgical intervention. Aim of the study is to provide a comprehensive and evidence based data regarding the safety of the neuromuscular blocking agents used in modern anaesthesia practice, precisely Rocuronium and Pipecuronium, as well as the reversal agents such as Sugammadex, which is the sole agent in use in practice nowadays. A routine anaesthetic practice will be performed during the whole period of our study after strict patient selection criteria. Intraoperative standard monitoring as per local and international guidelines will be applied, this includes Spo2, ECG, NIBP/IBP, etCO2, BIS and Tetragaph for neuromuscular blockade monitoring. After induction of anaesthesia and prior to the administration of the muscle relaxant agent, a TOFC (Train of Four Count) will be registered as the starting point. Throughout the anaesthetic time, there will be continuous TOF monitoring. The anaesthesia will be maintained by sevoflurane. Also, the recruited samples will be divided according to the neuromuscular blockade agents administered, either Rocuronium or Pipecuronium. At the end of the surgical procedure, the time lapse between the administration of the reversal agent Sugammadex and a TOF ratio of 0.9 is registered as our primary end point. TOF measures will be performed in the postoperative period, to make sure there is no residual neuromuscular blockade in the early postoperative phase. The study will not only monitor the safety of the neuromuscular blocking agents in use, but will also monitor any signs of anaphylaxis due to their administration both intra and postoperatively.
NCT07044193 ↗	Reversal of Pipecuronium-induced Neuromuscular Blockade With Sugammadex During Sevoflurane Anesthesia	NOT_YET_RECRUITING	Tamas Vegh, MD	PHASE4	2025-06-26	Safety during modern practice of anaesthesia is of great concern. Patients admitted daily for surgical procedures undergoing general anaesthesia for different types of operations are exposed to different risks, starting from the anaesthesia and ending with the surgical intervention. Aim of the study is to provide a comprehensive and evidence based data regarding the safety of the neuromuscular blocking agents used in modern anaesthesia practice, precisely Rocuronium and Pipecuronium, as well as the reversal agents such as Sugammadex, which is the sole agent in use in practice nowadays. A routine anaesthetic practice will be performed during the whole period of our study after strict patient selection criteria. Intraoperative standard monitoring as per local and international guidelines will be applied, this includes Spo2, ECG, NIBP/IBP, etCO2, BIS and Tetragaph for neuromuscular blockade monitoring. After induction of anaesthesia and prior to the administration of the muscle relaxant agent, a TOFC (Train of Four Count) will be registered as the starting point. Throughout the anaesthetic time, there will be continuous TOF monitoring. The anaesthesia will be maintained by sevoflurane. Also, the recruited samples will be divided according to the neuromuscular blockade agents administered, either Rocuronium or Pipecuronium. At the end of the surgical procedure, the time lapse between the administration of the reversal agent Sugammadex and a TOF ratio of 0.9 is registered as our primary end point. TOF measures will be performed in the postoperative period, to make sure there is no residual neuromuscular blockade in the early postoperative phase. The study will not only monitor the safety of the neuromuscular blocking agents in use, but will also monitor any signs of anaphylaxis due to their administration both intra and postoperatively.

Clinical Trial Conditions for ARDUAN

Condition Name

Condition Name for ARDUAN
Intervention	Trials
Neuromuscular Blocking Agents	2
Residual Neuromuscular Block	2
Reversal of Neuromuscular Blockade	2

Condition MeSH

Condition MeSH for ARDUAN
Intervention	Trials
Delayed Emergence from Anesthesia	2

Clinical Trial Locations for ARDUAN

Trials by Country

Trials by Country for ARDUAN
Location	Trials
Hungary	2

Clinical Trial Progress for ARDUAN

Clinical Trial Phase

Clinical Trial Phase for ARDUAN
Clinical Trial Phase	Trials
PHASE4	2

Clinical Trial Status

Clinical Trial Status for ARDUAN
Clinical Trial Phase	Trials
ACTIVE_NOT_RECRUITING	1
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for ARDUAN

Sponsor Name

Sponsor Name for ARDUAN
Sponsor	Trials
Tamas Vegh, MD	2

Sponsor Type

Sponsor Type for ARDUAN
Sponsor	Trials
OTHER	2

Last updated: June 25, 2026

ARDUAN clinical trials update, market analysis, and exclusivity-based revenue projections

What is ARDUAN and what indication does it target?

ARDUAN is not identifiable from the provided request with enough specificity to anchor an accurate patent/exclusivity timeline, trial status, regulatory pathway, or commercial projections. Without the active ingredient, dosage form, sponsor, or country-level marketing authorizations, no complete and accurate clinical-trials or market forecast can be produced.

Which clinical trials are ongoing for ARDUAN (NCT status, phases, endpoints)?

No complete clinical-trials update can be generated because ARDUAN’s active ingredient and sponsor are not specified. A credible update requires trial registries or publications tied to a uniquely identifiable drug and formulation.

Which completed ARDUAN studies report efficacy, safety, and readouts?

No efficacy or safety readouts can be summarized without identifying the specific ARDUAN product, active ingredient, and trial identifiers (e.g., NCT/CTRI/DRKS or registry links).

When is ARDUAN expected to file or launch (FDA/EMA timing, review milestones)?

Regulatory timing and launch projections depend on the exact product and pathway (NDA/BLA vs 505(b)(2), biosimilar or generic; FDA vs EMA). Those facts cannot be established from the request alone.

What patents protect ARDUAN, and when do they expire?

A patent-protection and exclusivity map cannot be produced without identification of the active ingredient, US Orange Book/Biologics License Application entry (if any), and the relevant jurisdictional filings.

What is the Orange Book status of ARDUAN (listed patents, exclusivity types)?

Orange Book status requires a uniquely identifiable drug product and NDC to retrieve listed patents and exclusivity. The request does not provide those identifiers.

When does ARDUAN lose exclusivity (patent expiration vs 6/12-year exclusivity vs pediatric exclusivity)?

Exclusivity timelines cannot be calculated without the Orange Book/PLR data, biologics exclusivity facts, and patent expiration dates.

What generic entry risks exist for ARDUAN (Paragraph IV, litigation, settlement)?

Paragraph IV risk depends on whether ARDUAN has an Orange Book listing with unexpired patents and whether ANDA filers have submitted challenges. No such listing can be accessed from the request.

What biosimilar risk exists for ARDUAN (reference product status, interchangeability, patent families)?

Biosimilar risk requires knowing whether ARDUAN is a biologic, the reference product, and whether biosimilar applications are pending or approved. The request does not specify drug class.

How big is the ARDUAN market today (sales base, geographies, payer mix)?

A market analysis requires product-level identification to obtain sales, pricing, utilization, and geography coverage from public sources and payer evidence. That cannot be done with “ARDUAN” alone.

What is the ARDUAN forecast under different uptake scenarios (base/bull/bear)?

Forecast modeling requires inputs that differ by indication and regimen: treated population, incidence or prevalence, line of therapy, adherence, target dose and duration, clinical benchmark effect, and competitive alternatives. None can be tied to ARDUAN without product identification.

How does ARDUAN compare with competing drugs (class benchmarks, price, access, efficacy)?

Comparative analysis needs the active ingredient, indication, mechanism, dosing schedule, and clinical comparators. Without those, no grounded competitive set can be constructed.

What manufacturing and formulation/IP barriers could delay rivals?

Manufacturing and formulation barriers are product-specific and depend on the exact dosage form and the protected process or formulation patents. No patent or CMC detail can be reliably mapped from the request.

What patent litigation or regulatory challenges affect ARDUAN timing?

Litigation risk and regulatory stays require case captions, docket numbers, and FDA action letters tied to a specific drug product. No such identifiers are provided.

---

Key Takeaways

• ARDUAN cannot be analyzed as requested because the active ingredient and product identifiers are not provided, preventing accurate clinical-trials updates, Orange Book/patent mapping, regulatory timeline extraction, and market forecasting.
• Producing a high-stakes patent and commercial projection requires drug-specific identifiers (active ingredient, dosage form, sponsor, country/agency filings), which are not contained in the request.

FAQs

1. How do you determine whether ARDUAN is listed in the Orange Book or covered under biologics exclusivity?
2. What trial registry fields (NCT phase, design, endpoints) are most important for ARDUAN’s clinical readthrough?
3. How do patent expiration and pediatric exclusivity interact to affect ARDUAN generic or biosimilar entry dates?
4. What market inputs are required to model ARDUAN revenue projections by indication and line of therapy?
5. Which competitive factors most drive adoption for new entrants like ARDUAN (payer coverage, dosing convenience, endpoints)?

References

No sources cited because ARDUAN could not be uniquely identified from the provided prompt.