CLINICAL TRIALS PROFILE FOR SORBITOL

All Clinical Trials for SORBITOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000159 ↗	Sorbinil Retinopathy Trial (SRT)	Completed	National Eye Institute (NEI)	Phase 3	1983-08-01	To evaluate the safety and efficacy of the investigational drug sorbinil, an aldose reductase inhibitor, in preventing the development of diabetic retinopathy and neuropathy in persons with insulin-dependent diabetes.
NCT00121433 ↗	Leptin and Endothelial Function	Completed	Amgen	Phase 4	2004-09-01	The purpose of this trial was to determine if injections of leptin would improve vascular function in normal-weight, healthy volunteers.
NCT00121433 ↗	Leptin and Endothelial Function	Completed	University of Michigan	Phase 4	2004-09-01	The purpose of this trial was to determine if injections of leptin would improve vascular function in normal-weight, healthy volunteers.
NCT00226616 ↗	Zinc Supplementation in Cholera Patients	Completed	Thrasher Research Fund	Phase 3	2000-11-01	Cholera is one of the leading causes of morbidity and mortality among children and adult in developing countries. We will evaluate the effect of supplementation of zinc on reduction of duration and severity of cholera. Since cholera is primarily a disease of older children and adults, we intend to study the effects of zinc supplementation among children of 3 to 14 years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea for less than 24 hours will be selected. After inclusion in the study, informed consent will be obtained from guardian explaining the full procedure in the hospital. The subjects will be randomized to receive either zinc or placebo until diarrhea resolves. History of illness and baseline information will be collected in the hospital through interview, which may take duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample will be taken to assess serum zinc level on admission after initial hydration and will be repeated on the day of recovery. This procedure carries a small risk of infection if not done under sanitary conditions; however, we will maintain proper sanitation, so there is no risk in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of random stool samples. Information obtained from history and the laboratory investigations of subject will be kept strictly confidential and no one other than the investigators of this study and the Ethics Committee of this Centre will/ has access to the information. The study will benefit the patients as study physician will do close observation, examination and will take care frequently, as research staff will monitor systematic progress and take necessary action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If the results of the study is positive, it will benefit the patients in their treatment during this study and thereafter. The data will be analyzed for clinical effects of zinc on diarrhea.The study will help to improve the treatment strategy of cholera in children. The study will use hospital records, which will be returned after completion of the study. Stool, urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.
NCT00226616 ↗	Zinc Supplementation in Cholera Patients	Completed	World Bank	Phase 3	2000-11-01	Cholera is one of the leading causes of morbidity and mortality among children and adult in developing countries. We will evaluate the effect of supplementation of zinc on reduction of duration and severity of cholera. Since cholera is primarily a disease of older children and adults, we intend to study the effects of zinc supplementation among children of 3 to 14 years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea for less than 24 hours will be selected. After inclusion in the study, informed consent will be obtained from guardian explaining the full procedure in the hospital. The subjects will be randomized to receive either zinc or placebo until diarrhea resolves. History of illness and baseline information will be collected in the hospital through interview, which may take duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample will be taken to assess serum zinc level on admission after initial hydration and will be repeated on the day of recovery. This procedure carries a small risk of infection if not done under sanitary conditions; however, we will maintain proper sanitation, so there is no risk in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of random stool samples. Information obtained from history and the laboratory investigations of subject will be kept strictly confidential and no one other than the investigators of this study and the Ethics Committee of this Centre will/ has access to the information. The study will benefit the patients as study physician will do close observation, examination and will take care frequently, as research staff will monitor systematic progress and take necessary action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If the results of the study is positive, it will benefit the patients in their treatment during this study and thereafter. The data will be analyzed for clinical effects of zinc on diarrhea.The study will help to improve the treatment strategy of cholera in children. The study will use hospital records, which will be returned after completion of the study. Stool, urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.
NCT00226616 ↗	Zinc Supplementation in Cholera Patients	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 3	2000-11-01	Cholera is one of the leading causes of morbidity and mortality among children and adult in developing countries. We will evaluate the effect of supplementation of zinc on reduction of duration and severity of cholera. Since cholera is primarily a disease of older children and adults, we intend to study the effects of zinc supplementation among children of 3 to 14 years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea for less than 24 hours will be selected. After inclusion in the study, informed consent will be obtained from guardian explaining the full procedure in the hospital. The subjects will be randomized to receive either zinc or placebo until diarrhea resolves. History of illness and baseline information will be collected in the hospital through interview, which may take duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample will be taken to assess serum zinc level on admission after initial hydration and will be repeated on the day of recovery. This procedure carries a small risk of infection if not done under sanitary conditions; however, we will maintain proper sanitation, so there is no risk in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of random stool samples. Information obtained from history and the laboratory investigations of subject will be kept strictly confidential and no one other than the investigators of this study and the Ethics Committee of this Centre will/ has access to the information. The study will benefit the patients as study physician will do close observation, examination and will take care frequently, as research staff will monitor systematic progress and take necessary action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If the results of the study is positive, it will benefit the patients in their treatment during this study and thereafter. The data will be analyzed for clinical effects of zinc on diarrhea.The study will help to improve the treatment strategy of cholera in children. The study will use hospital records, which will be returned after completion of the study. Stool, urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.

Clinical Trial Conditions for SORBITOL

Condition Name

Condition Name for SORBITOL
Intervention	Trials
Constipation	2
Intoxication	2
Severe Mental Illness	2
Charcot-Marie-Tooth Disease (CMT)	1

Condition MeSH

Condition MeSH for SORBITOL
Intervention	Trials
Tooth Diseases	3
Nerve Compression Syndromes	3
Hereditary Sensory and Motor Neuropathy	3
Charcot-Marie-Tooth Disease	3

Clinical Trial Locations for SORBITOL

Trials by Country

Trials by Country for SORBITOL
Location	Trials
United States	29
China	7
Ukraine	4
Turkey	4
Canada	4

Trials by US State

Trials by US State for SORBITOL
Location	Trials
New York	3
Kansas	3
California	3
Washington	2
Ohio	2

Clinical Trial Progress for SORBITOL

Clinical Trial Phase

Clinical Trial Phase for SORBITOL
Clinical Trial Phase	Trials
PHASE3	2
PHASE2	2
Phase 4	10

Clinical Trial Status

Clinical Trial Status for SORBITOL
Clinical Trial Phase	Trials
Completed	17
Recruiting	10
Not yet recruiting	4

Clinical Trial Sponsors for SORBITOL

Sponsor Name

Sponsor Name for SORBITOL
Sponsor	Trials
Yuria-Pharm	4
Sahlgrenska University Hospital, Sweden	3
ScandiBio Therapeutics AB	3

Sponsor Type

Sponsor Type for SORBITOL
Sponsor	Trials
Other	52
Industry	21
NIH	1

Sorbitol clinical trials update, market analysis, and 2025–2035 projection

Last updated: May 20, 2026

Sorbitol is a widely used sugar alcohol in oral and parenteral medicines and as an excipient. There is no single, FDA-approvable “sorbitol drug product” with a patent estate and Orange Book exclusivity analogous to a proprietary small molecule. Commercially, the relevant opportunity is tied to (1) branded/labeled therapeutic uses where sorbitol is an active ingredient (not merely a formulation excipient), and (2) demand for sorbitol as a bulk ingredient used in drug manufacturing, medical products, and adjacent consumer/industrial applications. This update focuses on clinical-trial activity and a market outlook built around ingredient demand and therapeutic positioning rather than a single-asset pipeline.

What sorbitol clinical trials are ongoing and what do the results show?

Are there recent phase 2/3 sorbitol trials in constipation, bowel prep, or enteral nutrition?

No complete, auditable trial register set for “sorbitol” as an investigational therapeutic with phase 2 or phase 3 endpoints is available in the provided information. Sorbitol is commonly studied through (a) older comparative studies for osmotic laxation and bowel preparation and (b) product-level trials for combination therapies where sorbitol is one component. Without a verifiable, current trial list, a precise “ongoing trials” update cannot be constructed to a standard suitable for litigation, investment, or licensing decisions.

What endpoints are typically used where sorbitol is active?

When sorbitol is used therapeutically, endpoints in the literature typically include:

• time to bowel movement (constipation)
• stool frequency and stool consistency (Bristol Stool Form Scale or equivalent)
• bowel cleansing quality scores (bowel prep)
• tolerability and adverse event rates, including dehydration and electrolyte shifts

How does sorbitol differ clinically from other osmotics (PEG, lactulose, magnesium)?

Clinical decision points usually involve:

• onset time and stool quality
• safety profile in renal impairment or dehydration risk
• tolerability (cramping, nausea, bloating)
• dosing volume and adherence

How big is the sorbitol market and what drives growth?

What is the sorbitol market scope: ingredient vs finished drug

For investment-grade forecasting, sorbitol demand is best modeled on:

• bulk sorbitol used as a pharmaceutical excipient (stabilizers, bulking agents, coating aids, humectants)
• medical-grade sorbitol used in liquid formulations and certain osmotic products
• demand in food, personal care, and industrial chemical intermediates, which often sets the global price ceiling/floor and capacity availability

Key demand drivers

1. Pharmaceutical formulation consumption
   Sorbitol is used to control viscosity and moisture, improve palatability, and serve as a bulking agent in syrups, oral solutions, chewables, and other dosage forms.

2. Osmotic laxation and bowel-cleansing use cases
   Where sorbitol-containing products are marketed as therapeutic or part of bowel prep kits, demand tracks patient volumes and formulary adoption.

3. Supply chain and capacity economics
   Sorbitol supply is linked to upstream hydrogenation capacity and commodity input pricing. Capacity additions in Asia have historically affected global price dynamics, which in turn shapes margin structures for ingredient makers.

What is the sorbitol competitive landscape in pharma-facing supply?

Who are the main global sorbitol suppliers?

Sorbitol is supplied by large specialty and commodity chemical firms and by chemical subsidiaries serving the food and pharma excipient markets. In most markets, the competitive axis is:

• ability to supply pharmaceutical-grade material at scale
• regulatory dossiers and quality systems (GMP, DMF support, impurity specifications)
• stable delivery contracts and pricing formulas tied to upstream costs

How do ingredient suppliers position against excipient alternatives?

Primary competition comes from:

• hydrogenated glucose syrups and alternative polyols (xylitol, mannitol, lactitol) depending on formulation needs
• PEG-based excipients where humectancy and solubility requirements overlap
• locally manufactured excipients where qualification timelines create “switching frictions”

When does sorbitol lose exclusivity or face patent barriers?

Is there an Orange Book listing for “sorbitol” as a drug?

Sorbitol is generally not governed by a single, proprietary exclusivity anchor like a branded active pharmaceutical ingredient. In the US, many excipient-based uses are not “drug exclusivity” targets in the Orange Book sense. Market access and generic/brand boundaries typically relate to:

• product-level approvals (if sorbitol is the active ingredient in a specific labeled product)
• formulation/manufacturing patent coverage for a specific dosage form and process
• trademarks and line-extension lifecycle management

What are the real IP risk areas for sorbitol-linked products?

Where sorbitol is active in a particular product label, risk is usually concentrated in:

• manufacturing process patents (purification, crystallization, impurity profiles)
• formulation patents (specific ratios, stabilizers, particle size, coatings)
• method-of-use patents tied to dosing regimens, bowel-prep protocols, or constipation treatment claims

No defensible patent expiration timetable for a “sorbitol” asset can be produced without tying to a specific branded/specified NDA/ANDA/BLA and its Orange Book listings.

What formulation patents protect sorbitol-based products and how strong are they?

What patent themes apply to sorbitol formulations?

Common protectable angles include:

• controlled-release or taste-masked compositions where sorbitol is used as a matrix or bulking/humectant component
• aqueous solution stabilization systems
• solid dosage form engineering where sorbitol affects crystallinity and dissolution
• impurity-spec driven manufacturing methods that reduce sorbitan, sorbitans, and other byproducts

How strong are such patents in practice?

For ingredient-based positions, enforceability depends on:

• whether claims are limited to specific compositions and processes
• whether generic manufacturers can change formulation ratios, grade, or process without infringing
• whether claims are directed to methods used in manufacturing rather than product composition

What generic entry risks exist for sorbitol-based laxatives or bowel prep products?

What drives entry risk: product competition vs excipient supply

Entry is less about “generic sorbitol” and more about:

• whether the finished product’s label and application are protected
• whether there are formulation/manufacturing patents for that product
• whether FDA-approved product-specific data exclusivity exists

In most cases, ingredient supply does not prevent entry, but product-level regulatory/IP status does.

What FDA regulatory status applies to sorbitol for pharma use?

How is sorbitol regulated

Sorbitol is commonly used as:

• an excipient in approved drug products
• an active ingredient in certain approved products depending on the jurisdiction and label

Regulatory treatment then depends on the finished dosage form and application.

What matters for market entry

From a developer and supplier standpoint, the practical regulatory hurdles are:

• quality specifications and impurity limits meeting pharmacopeial or dossier standards
• control of residuals and byproducts tied to manufacturing route
• stability and compatibility with packaging and co-formulated ingredients

Market projection for sorbitol 2025–2035: base case, drivers, and downside/upside

Because sorbitol is not a single proprietary “drug,” projections must be framed as a market for sorbitol ingredient and sorbitol-containing pharmaceutical products.

Base case (ingredient demand)

Forecast logic typically models:

• volume growth tied to pharmaceutical excipient consumption and medical use cases
• industrial demand resilience versus cyclic chemical demand
• pricing anchored to global polyol supply and upstream hydrogenation economics

Upside case

• faster-than-expected growth in oral solid and liquid dosage forms using sugar alcohol excipients
• additional regulatory or formulary adoption of sorbitol-containing osmotic products
• capacity constraints or price increases due to supply disruptions upstream

Downside case

• substitution to alternative polyols where performance and cost shift
• margin compression from oversupply and price resets
• slower growth in pharmaceutical excipient volumes

Key projection inputs that must be mapped for an auditable forecast

Any high-integrity projection requires a dataset that links:

• sorbitol grade sales (pharma/excipients vs food/industrial)
• regional shares (US/EU/China/India/LatAm)
• installed capacity and operating rates
• pharma pipeline conversion rates into formulation adoption
• historical price-volume relationships and contract structures

No such dataset is contained in the prompt, so no numeric forecast can be stated without fabricating inputs.

Key takeaways

• Sorbitol’s market opportunity in pharma is primarily a function of excipient and medical formulation demand, not a single proprietary “sorbitol drug” with Orange Book exclusivity.
• A credible clinical-trials update requires a verified current trial register list by sponsor, phase, and endpoint; that is not available in the provided information.
• IP and generic-entry analysis must be tied to specific sorbitol-containing finished products (NDA/ANDA labels) rather than “sorbitol” as a standalone substance.
• A numeric 2025–2035 projection cannot be produced to an investment-grade standard without audited market sizing inputs (volume, price, grade mix, and regional demand shares).

FAQs

Is sorbitol approved by FDA as a drug ingredient for constipation or bowel prep?

Yes, sorbitol is used in approved medicinal products depending on label and jurisdiction, but “sorbitol” alone is not a single FDA-branded asset with one exclusivity profile.

What are the most common adverse events associated with sorbitol-containing laxatives?

Commonly reported effects are GI intolerance such as cramping, bloating, and diarrhea, with risk of dehydration and electrolyte imbalance in susceptible patients.

Can sorbitol be used as a pharmaceutical excipient in oral liquid and solid dosage forms?

Yes. Sorbitol is widely used as a humectant, bulking agent, and formulation aid across multiple oral dosage types.

Do patent estates exist for sorbitol as an ingredient?

Sorbitol ingredient production is generally not protected by a broad, single estate; patent coverage is usually product- or process-specific for particular finished formulations.

What competes with sorbitol in osmotic constipation treatment?

Typical competitors include PEG-based regimens, lactulose, and magnesium-containing osmotics, depending on country guidance and product availability.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. US National Library of Medicine. ClinicalTrials.gov. NLM/NIH.
3. World Health Organization. WHO Model List of Essential Medicines and pharmacopoeial standards for polyols (contextual excipient guidance).