CLINICAL TRIALS PROFILE FOR ASCORBIC ACID

505(b)(2) Clinical Trials for Ascorbic Acid

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT01533090 ↗	Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy	Completed	Catholic University of the Sacred Heart	N/A	2010-04-01	The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the procedure is safe and effective. It has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been shown to provide adequate colon cleansing and better tolerability. LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.

All Clinical Trials for Ascorbic Acid

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000595 ↗	Evaluation of Subcutaneous Desferrioxamine as Treatment for Transfusional Hemochromatosis	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1978-01-01	To determine whether deferoxamine prevented the complications of transfusional iron overload.
NCT00006021 ↗	Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vitamin C may increase the effectiveness of arsenic trioxide by making cancer cells more sensitive to the drug. PURPOSE: Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C in treating patients who have recurrent or refractory multiple myeloma.
NCT00006021 ↗	Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma	Completed	University of Miami	Phase 1/Phase 2	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vitamin C may increase the effectiveness of arsenic trioxide by making cancer cells more sensitive to the drug. PURPOSE: Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C in treating patients who have recurrent or refractory multiple myeloma.
NCT00085345 ↗	Melphalan, Arsenic Trioxide, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma	Withdrawn	Oncotherapeutics	Phase 2	1969-12-31	RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic acid, work in different ways to stop cancer cells from dividing so they stop growing or die. Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making them more sensitive to the drugs. PURPOSE: This phase II trial is studying how well giving melphalan together with arsenic trioxide and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.
NCT00102271 ↗	Nitrite Infusion Studies	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 1	2005-01-19	This study will examine 1) how nitrite (a natural blood substance that relaxes blood vessels) increases blood flow and lowers blood pressure, and 2) how to increase the effects of nitrite on blood pressure. Healthy volunteers between 21 and 40 years of age may be eligible for this study. They must be non-smokers and have no history of high blood pressure, high cholesterol, or diabetes. Candidates are screened with a medical history, physical examination, electrocardiogram, and blood tests. This study is either done in the NIH Clinical Center intensive care unit or on the general clinical ward. Participants are enrolled in Part A of the study. After completion of Part A participants will be enrolled in Part B of the study. Part A: Participants lie in a reclining chair during the study. Small catheters (plastic tubes) are inserted into an artery and vein in the forearm. Another tube is placed in the vein of the opposite arm. Blood pressure cuffs are placed around the upper arm and wrist, and a strain gauge (a rubber band-like device) is placed around the forearm. This device helps us to measure blood flow through the arm. When the blood pressure cuffs are inflated, blood flows into the forearm, stretching the strain gauge at a rate proportional to the blood flow. Pressure cuffs and a strain gauge are also placed on the other arm. After 20 minutes, blood pressure and blood flow are measured in both forearms. Then blood is drawn from the tube in the right vein to measure blood counts, proteins, and other chemicals. Participants then are given small doses of either saline, ascorbic acid, or a medicine called oxypurinol, a form of a drug that is often taken to prevent gout. After 30 minutes, sodium nitrite is injected in increasing doses into the artery for 30 minutes. Blood flow is measured and blood is drawn every 5 minutes during the infusion. At the end of the 30 minutes, blood is drawn from the vein every 30 minutes for 3 hours. After 3 hours, sodium nitrite infusions are restarted for 2 hours and blood flow is measured and samples collected every 30 minutes during this period. Part B: Participants lie in a reclining chair during the study. A small catheter (plastic tube) is placed in the artery of the left forearm to draw blood samples. A larger catheter called a central line is placed in a deeper vein in the neck. Another tube is advanced through the central line into the chambers of the heart, through the heart valve, and into the lung artery to measure pressures in the heart and lungs. Blood is drawn after 30 minutes to obtain baseline measurements. Then saline (sterile salt water) is put into the tube in the lung artery. Blood pressure cuffs are placed around the upper arm and wrist, and a strain gauge (a rubber band-like device) is placed around the forearm, which helps us to measure flow through the arm. When the cuffs are inflated, blood flows into the forearm, stretching the strain gauge at a rate proportional to the blood flow. Pressure cuffs and a strain gauge are also placed on the other arm. After 20 minutes, blood pressure and blood flow are measured in the forearm and blood samples are drawn from the tube in the left artery to measure blood counts, proteins, and other chemicals. Subjects then breathe a mixture of oxygen and nitrogen through a facemask for 30 minutes, then room air for 30 minutes, and then the oxygen and nitrogen mixture for another 30 minutes. While breathing the mixture the second time, sodium nitrite is injected through the tube in the artery in three increasing doses for 5 minutes each. Every 5 minutes during the infusion blood is drawn from the tubes in the neck. Forearm blood flow is also measured every 5 minutes. After 30 minutes, the subject breathes room air for 3 hours and 15 minutes and then the sodium nitrite is injected again in three increasing doses for 5 minutes each. Every 5 minutes during the infusion blood is taken from the tube in the neck and forearm blood flow is measured
NCT00112879 ↗	Arsenic Trioxide, Ascorbic Acid, Dexamethasone, and Thalidomide in Treating Patients With Multiple Myeloma	Withdrawn	The Cleveland Clinic	Phase 2	1969-12-31	RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving arsenic trioxide together with ascorbic acid, dexamethasone, and thalidomide may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with ascorbic acid, dexamethasone, and thalidomide work in treating patients with multiple myeloma.
NCT00140166 ↗	Treatment of Acute Schizophrenia With Vitamin Therapy	Completed	International Schizophrenia Foundation	Phase 4	2005-07-01	Controlled studies using the orthomolecular approach have been few (Deutsch, Ananth, & Ban, 1977). Those that were done were performed in chronic schizophrenia or in populations that included bipolar and schizoaffective patients. Both of these diagnostic groups are not today considered to benefit from the orthomolecular approach. Moreover, some negative studies of high-dose niacin were done in patients who were not otherwise given general counseling for good diet as described above. Therefore, this proposal is to study in a controlled manner carefully defined first onset schizophrenic patients using the protocol advocated by Osmond and Hoffer (1962). Patients can enter the study if they have been ill less than 1 year and are in their first hospitalization.

Clinical Trial Conditions for Ascorbic Acid

Condition Name

Condition Name for Ascorbic Acid
Intervention	Trials
Sepsis	11
Septic Shock	10
Colonoscopy	7
Multiple Myeloma	5

Condition MeSH

Condition MeSH for Ascorbic Acid
Intervention	Trials
Multiple Myeloma	13
Pancreatic Neoplasms	12
Neoplasms, Plasma Cell	12
Sepsis	12

Clinical Trial Locations for Ascorbic Acid

Trials by Country

Trials by Country for Ascorbic Acid
Location	Trials
United States	134
Korea, Republic of	22
Egypt	15
Spain	12
Italy	7

Trials by US State

Trials by US State for Ascorbic Acid
Location	Trials
Pennsylvania	12
New York	10
California	10
Arizona	8
Massachusetts	7

Clinical Trial Progress for Ascorbic Acid

Clinical Trial Phase

Clinical Trial Phase for Ascorbic Acid
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	1
PHASE2	4

Clinical Trial Status

Clinical Trial Status for Ascorbic Acid
Clinical Trial Phase	Trials
Completed	115
Recruiting	32
Unknown status	24

Clinical Trial Sponsors for Ascorbic Acid

Sponsor Name

Sponsor Name for Ascorbic Acid
Sponsor	Trials
National Cancer Institute (NCI)	13
Thomas Jefferson University	7
Ain Shams University	6

Sponsor Type

Sponsor Type for Ascorbic Acid
Sponsor	Trials
Other	340
Industry	40
NIH	21

Last updated: April 28, 2026

What is the current clinical-trials footprint, market position, and 2026-2031 outlook for Ascorbic Acid?

Ascorbic acid (vitamin C) is a widely manufactured commodity active ingredient used across nutrition, oral OTC supplementation, and prescription-adjacent hospital use (notably in certain parenteral formulations). The “clinical trials update” is constrained because many studies are not new drug-development programs and are frequently nutrition/outcome studies, reformulations, or comparative bioavailability work rather than late-stage, registrational pipelines.

Given the lack of a single, unified “drug” label (ascorbic acid is sold in multiple dosage forms and strengths and is not protected by a broad proprietary patent moat), market analysis must be framed as commodity and segment demand (supplementation, food fortification, and medical/institutional supply), plus pricing and volume dynamics.

Bottom line: the opportunity is dominated by (1) volume growth tied to supplementation habits and fortification policies, (2) substitution across forms (tablet, effervescent, powder, IV), and (3) supply-side economics (China-led manufacturing, capacity cycles, and feedstock costs). Clinical-trial activity exists but is not typically “drug-unique” and rarely dictates market exclusivity.

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What is the clinical-trials update for Ascorbic Acid (vitamin C) overall?

Trial profile (how “clinical trials update” typically looks for ascorbic acid)

Most “ascorbic acid” clinical research falls into four buckets:

1. Nutritional adequacy and health outcomes
   • Trials assessing deficiency correction, immune markers, oxidative stress biomarkers, or population-level outcomes.
2. Supportive care and adjunctive regimens
   • Studies where vitamin C is used as an adjunct in specific clinical contexts rather than as a standalone investigational product with a single proprietary indication.
3. Formulation and delivery comparisons
   • Bioavailability, dissolution, stability, and tolerability comparisons across salts (ascorbate forms) and delivery systems (effervescent, chewable, sustained release, powder mixes).
4. Dose-ranging studies
   • Trials exploring higher-dose regimens (often oral) and parenteral dosing strategies.

What is most actionable for investors and R&D planners

For market and investment decisions, the key signal is not “how many trials exist,” but whether there is a registrational-grade program that:

• uses a distinct formulation with clear differentiation,
• runs well-controlled endpoints, and
• targets a specific label likely to support pricing beyond commodity levels.

For ascorbic acid itself, that registrational signal is historically limited because the active ingredient is mature and widely available.

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What is the current market position of Ascorbic Acid by segment and use case?

Demand drivers

Ascorbic acid demand is driven by:

• Supplementation
  • Oral vitamin C tablets, chewables, powders, and effervescents.
• Food and beverage fortification
  • Fortification standards and consumer product inclusion.
• Medical/institutional use
  • Mainly parenteral formulations, premixes, and hospital procurement linked to shortage dynamics and supportive-care protocols.

Supply and pricing dynamics (commodity behavior)

Ascorbic acid behaves like a commodity chemical active:

• Price and availability hinge on manufacturing capacity utilization, energy and feedstock costs, and China export flows.
• Industrial and food-grade specifications often translate into pharma-grade supply through downstream QA and regulatory controls.
• Volume growth can be muted by price cycles, even when unit demand rises.

Competitive landscape (who “wins” commercially)

Commercial strength tends to concentrate with manufacturers and suppliers that can:

• secure stable contracts with supplement brands and food companies,
• offer consistent pharma-grade documentation where required,
• manage cost cycles and inventory planning.

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How large is the global opportunity and where is growth most likely?

A robust, quantitative forecast must anchor to an auditable baseline. In the absence of a single agreed “ascorbic acid only” market size with the same scope across sources, the most decision-useful projection is directional and segment-specific:

Projection logic (what will likely move the numbers)

1. Supplement use trends
   • Aging populations and chronic-disease awareness support steady demand for oral vitamin C.
2. Fortification policies
   • Regulatory frameworks in food and beverage products influence long-run consumption.
3. Clinical use in hospitals
   • Institutional protocols change with evidence cycles, but parenteral vitamin C remains a procurement category where supply continuity matters.
4. Form-factor shifts
   • Effervescent and powder formats often track consumer convenience preferences and retailer promotions.

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What is the 2026 to 2031 market outlook (directional projection) for Ascorbic Acid?

Base-case (commodity-consistent) outlook

• Moderate unit growth in consumption driven by supplementation and fortification.
• Limited pricing power due to commodity supply and multiple competing producers.
• Incremental margin opportunities tied to higher specification grades, turnkey packaging formats, and contract manufacturing for brand owners.

Upside scenarios

• Stronger-than-expected institutional uptake in supportive regimens.
• Regulatory or public-health shifts that increase fortification or consumption targets.
• Demand substitution into higher-value forms (effervescent, sustained release, or specialized salts) that can carry better pricing for branded or semi-branded suppliers.

Downside scenarios

• Prolonged price compression due to capacity expansion.
• Regulatory tightening on supplement claims that reduces marketing intensity (impacting branded volumes).
• Cost shocks from energy or feedstock supply affecting manufacturers’ margins and leading to demand volatility.

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What clinical-development strategies are actually viable for Ascorbic Acid “drug-like” value?

Because ascorbic acid is not typically protected as a novel drug active, “value capture” strategies require differentiation beyond the molecule:

• Formulation differentiation
  • Stable, controlled-release, or improved bioavailability product designs.
• Clear clinical endpoint studies
  • Trials targeting specific outcome measures rather than biomarker-only endpoints.
• Regulatory pathway alignment
  • Using a route that supports label language without running into supplement-claim limitations (depending on geography).
• Targeted niches
  • Where supportive care protocols can specify product attributes (e.g., IV dosing form, solubility, excipient profile).

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Key takeaways

• Clinical-trials activity exists for ascorbic acid but is largely non-proprietary: nutrition/outcomes studies, adjunctive use, and formulation comparisons rather than a single dominant registrational drug program.
• Market behavior is commodity-like with demand anchored in supplementation, fortification, and institutional procurement.
• 2026 to 2031 outlook points to moderate volume growth with limited pricing power, and value capture concentrated in supply reliability, grade/spec differentiation, and packaging/form-factor economics.
• Investment and R&D focus should be on formulation and evidence that supports specific label differentiation, not on the underlying active alone.

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FAQs

1) Is ascorbic acid considered a “drug pipeline” category for investors?

No. It is generally a commodity active where most evidence generation is not tied to a single proprietary registrational product.

2) Which segment usually drives incremental demand most consistently?

Oral supplementation and food fortification tend to anchor steadier long-run demand; institutional use fluctuates with clinical practice.

3) Why do clinical trials not translate directly into pricing power for ascorbic acid?

Because the molecule is widely available from many suppliers and is not typically protected by enforceable exclusivity.

4) What type of trial design would matter commercially?

Endpoint-driven studies that support a specific, regulator-aligned claim tied to a differentiated formulation or defined clinical use.

5) Where can margins improve despite commodity pricing?

On higher-spec pharma/institutional grades, reliable supply contracts, and higher-value form factors (with evidence-backed tolerability or delivery advantages).

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References (APA)

[1] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. https://clinicaltrials.gov/
[2] European Medicines Agency. (n.d.). EMA guidance and product information databases. https://www.ema.europa.eu/
[3] World Health Organization. (n.d.). Micronutrient and nutrition resources. https://www.who.int/