CLINICAL TRIALS PROFILE FOR FORANE

All Clinical Trials for FORANE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00521612 ↗	Sevoflurane vs. Isoflurane for Low-Flow General Anaesthesia for Abdominal Surgery	Completed	General Hospital Dubrovnik	N/A	2007-09-01	Two groups of patients are going to have abdominal surgery with low-flow general anaesthesia. Group A (sevoflurane group, experimental group) will use volatile anaesthetic sevoflurane. Group B (isoflurane group, control group) will use volatile anaesthetic isoflurane. It will be observed differences between volatile anaesthetic sevoflurane and volatile anaesthetic isoflurane for providing low-flow general anaesthesia for abdominal surgery. Duration of this randomised controled trial will be approximately 2 months. Estimated sample size will be 82 persons (41 in sevoflurane group and 41 in isoflurane group).
NCT00615472 ↗	Intravenous Versus Inhalational Anesthesia in Parkinson's Disease	Terminated	Columbia University	N/A	2003-10-01	Parkinson's disease is a common progressive degenerative disease affecting 3% of all patients over the age of 65. Given their age and frailty, these patients frequently require surgical procedures with general anesthesia. However, after surgery, patients with Parkinson's disease have longer hospital stays and a greater chance of not returning to independent living compared to age-matched controls (Berman MF, unpublished data). In part, this is due to a higher rate of post-operative delirium, which had an incidence of 60% in this population in one study. There is anecdotal evidence from neurologists specializing in movement disorder suggesting that there is also significant deterioration in parkinsonian motor symptoms and cognition lasting for months or years following surgery and anesthesia. The basis for this deterioration is unknown. We hypothesize that these problems are caused by particular medications used during inhaled anesthesia for surgical procedures.
NCT00815269 ↗	Vasodilation Effect of Inhalational Anesthetics	Completed	Nanjing Medical University	N/A	2008-12-01	Previous studies on animals suggest that inhalational anesthetics can reduce vascular tension in vitro resulting in vasodilation and decrease in blood pressure. This role for inhalational anesthetics has essential clinical implications such as the condition of sepsis or septic shock or other shock-associated states during which the blood vessel constricts strongly and leads to circulation dysfunction. The vasodilation property of these anesthetics including halothane, isoflurane, sevoflurane, desflurane and enflurane enables them to be better options than other general anesthetics in many clinical conditions needing the vasculature to be dilated. The investigators hypothesized that these inhalational anesthetics can evoke vasodilation measured with ultrasonography during general anesthesia in vivo as the in vitro studies displayed.

Clinical Trial Conditions for FORANE

Condition Name

Condition Name for FORANE
Intervention	Trials
Anaesthesia	1
Anesthesia Recovery Period	1
Cardiovascular Diseases	1

Condition MeSH

Condition MeSH for FORANE
Intervention	Trials
Parkinson Disease	1
Cardiovascular Diseases	1
Problem Behavior	1

Clinical Trial Locations for FORANE

Trials by Country

Trials by Country for FORANE
Location	Trials
United States	2
Croatia	1
Turkey	1
China	1
South Africa	1

Trials by US State

Trials by US State for FORANE
Location	Trials
New York	2

Clinical Trial Progress for FORANE

Clinical Trial Phase

Clinical Trial Phase for FORANE
Clinical Trial Phase	Trials
Phase 4	2
N/A	4

Clinical Trial Status

Clinical Trial Status for FORANE
Clinical Trial Phase	Trials
Completed	3
Terminated	2
Recruiting	1

Clinical Trial Sponsors for FORANE

Sponsor Name

Sponsor Name for FORANE
Sponsor	Trials
General Hospital Dubrovnik	1
Columbia University	1
Nanjing Medical University	1

Sponsor Type

Sponsor Type for FORANE
Sponsor	Trials
Other	6

Forane (Isoflurane): Clinical Trials Update, Market Analysis, and Projection

Last updated: May 4, 2026

What is Forane, and which product is this analysis about?

Forane is a brand of isoflurane (inhalation anesthetic). It is an established, off-patent small-molecule anesthetic used for maintenance and induction in surgical anesthesia.

Because Forane is not a new biologic or novel small molecule, the commercial and regulatory story is dominated by:

• ongoing product supply and usage patterns in established surgical settings
• regulatory listings across jurisdictions
• pricing and competitive positioning versus other inhalational anesthetics

What does “clinical trials update” mean for Forane (isoflurane) in 2024–2026?

For an off-patent inhaled anesthetic, “clinical trials update” typically concentrates on:

• comparative clinical studies versus other inhalational agents (e.g., sevoflurane, desflurane)
• clinical evaluations focused on anesthesia depth monitoring, emergence profiles, operating room efficiency, and special populations
• formulation, delivery system, and safety surveillance rather than new mechanism trials

Clinical development status (market-relevant framing)

No evidence in the public domain indicates new, late-stage (Phase 3/registrational) development for Forane specifically that would change regulatory standing or materially expand labeled use. Commercial dynamics still track to:

• surgical procedure volumes
• market share among inhaled agents
• tender/pricing behavior
• regional supply stability

What is typically being studied for isoflurane brands like Forane?

The recurring study themes in the literature for isoflurane include:

• emergence and recovery comparisons versus other volatile anesthetics
• hemodynamic profiles and anesthetic depth titration strategies
• outcomes in pediatric and geriatric cohorts
• environmental/occupational exposure management, because volatile anesthetics are handled in OR anesthesia workflows

What is the competitive landscape for inhalational anesthesia (isoflurane vs alternatives)?

In inhalational anesthesia markets, isoflurane competes on a three-part axis:

1. clinical profile (cardiovascular effects, recovery time, airway irritation)
2. availability and price (tendering and hospital formularies)
3. gas transport and vaporizer ecosystem (compatibility with hospital anesthesia machines)

Key substitutes that pressure isoflurane pricing and uptake

Hospitals often select among:

• sevoflurane (high uptake for induction, favorable recovery profile)
• desflurane (fast kinetics, cost and delivery considerations)
• halothane (reduced use due to safety profile and regulatory tightening in many regions)

Strategic implication for Forane

For an established brand like Forane, competitive headwinds typically appear as:

• share migration to sevoflurane where clinicians and institutions prioritize recovery and induction workflow
• tender-led volume shifts where isoflurane wins on price and supply reliability

What is Forane’s market demand driver set?

Isoflurane demand is driven by:

• number of surgeries requiring inhalational maintenance anesthesia
• OR throughput and the mix of elective vs emergency cases
• hospital formulary behavior (substitution across volatiles)
• procurement pricing (bulk contracting, regional distributor pricing)

Major use settings

Forane is used in:

• inpatient operating rooms for general anesthesia maintenance
• procedures where institutions use vaporizer systems compatible with isoflurane

Pricing and contracting dynamics

Pricing tends to reflect:

• procurement cycles (national/regional tenders)
• competition with sevoflurane and desflurane within the same anesthesia infrastructure
• supply continuity for volatile anesthetics

What is the market size and growth outlook for isoflurane/volatile anesthetics?

The inhalational anesthetics market is typically forecast using:

• surgical volume growth (population growth, aging, procedure expansion)
• adoption of general anesthesia in outpatient and ambulatory surgery
• substitution among volatile agents

Projection logic for Forane specifically

Forane’s revenue trajectory depends more on share and net price than on new demand creation, because:

• surgical volume growth is broadly captured by all volatiles
• isoflurane share fluctuates against sevoflurane and desflurane

What is the near-term (2024–2028) forecast for Forane revenue and volume?

A practical projection framework for an off-patent anesthetic brand is:

• baseline surgical volume growth (mid-single digits in mature markets; higher in emerging markets)
• substitution effects (sevoflurane tends to pull share where budgets allow)
• pricing behavior (tender-driven price pressure)

Market projection ranges (directional, not point estimates)

Most likely outcome (2024–2028):

• volume grows in line with procedure growth
• revenue per unit trends flat to slightly down in competitive regions due to procurement pressure
• net revenue growth is modest unless Forane gains share in price-sensitive tenders

Drivers that can improve Forane performance

• wins in cost-led tenders against higher-cost alternatives
• supply reliability and regional distributor strength
• formulary stability in hospitals that already have isoflurane vaporizer usage patterns

Drivers that can reduce Forane performance

• formulary switches to sevoflurane in induction-heavy settings
• tighter environmental controls that shift OR behavior and procurement preferences (less direct, but can influence logistics and adoption patterns)

What regulatory and labeling considerations affect commercialization?

Forane’s commercialization is constrained less by labeling expansions and more by:

• ongoing compliance with drug product regulations and manufacturing quality standards
• pharmacovigilance and safety reporting requirements
• supply chain and manufacturing continuity for volatile anesthetic products

In practice, regulatory risk for an established inhalation anesthetic generally centers on:

• GMP compliance
• manufacturing site performance
• product availability

What clinical evidence is most likely to matter to formulary decisions?

For hospital purchasing committees, “evidence” often means:

• consistent intraoperative stability and predictable recovery
• compatibility with hospital anesthesia protocols
• staff familiarity and vaporizer maintenance requirements

Studies that can influence adoption include:

• comparative recovery profiles between isoflurane and sevoflurane/desflurane
• tolerability outcomes in pediatric and geriatric anesthesia
• occupational exposure controls and workflow feasibility

What should investors and R&D leaders track for Forane-like products?

For an established volatile anesthetic, the investment and operational watchlist is:

• tender outcomes at regional and national levels
• net price changes by country or distributor
• supply continuity events (batch shortages, manufacturing disruptions)
• share shifts among inhalational agents (from isoflurane to sevoflurane and vice versa)
• usage mix: inpatient vs ambulatory care and induction vs maintenance patterns

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Key Takeaways

• Forane is isoflurane, an established inhalation anesthetic where new Phase 3 registrational trials are not the main driver of market performance.
• Clinical literature typically supports comparative and workflow-related outcomes, which feed formulary decisions more than brand-new labeled expansions.
• Near-term demand growth is mainly surgical volume growth, while brand performance is mainly share and net price versus sevoflurane and desflurane.
• The most likely 2024–2028 pattern is modest growth in volume with flat-to-slightly down revenue per unit in competitive procurement markets.
• For decision-making, the best indicators are tender wins/losses, pricing, and supply continuity, not late-stage clinical pipelines.

FAQs

1) Does Forane have ongoing Phase 3 trials that will expand its labeled use?

No public-facing indication suggests a new registrational Phase 3 pathway that would materially change labeled indications for Forane.

2) What competes most directly with Forane in hospitals?

Sevoflurane and desflurane are the most common alternatives in volatile anesthetic procurement decisions.

3) What determines Forane market share in mature markets?

Formulary position and purchasing tenders, combined with recovery and workflow preferences under current OR protocols.

4) How does outpatient surgery affect isoflurane demand?

Outpatient procedure growth can increase total anesthesia demand, but agent mix can shift toward alternatives favored for induction or recovery timing.

5) What operational risk matters most for Forane commercialization?

Supply continuity and manufacturing quality performance, which are critical for volatile anesthetic availability.

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References

[1] U.S. Food and Drug Administration. Drug Safety and Availability information for volatile anesthetics and drug product labeling resources. (FDA website).
[2] ClinicalTrials.gov. Search results for isoflurane/inhalational anesthetic comparative studies and ongoing interventional trials. (ClinicalTrials.gov database).
[3] World Health Organization (WHO). Surgical care and anesthesia service utilization background material relevant to procedure volume trends. (WHO publications).