Last Updated: June 8, 2026

CLINICAL TRIALS PROFILE FOR ASCORBIC ACID


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ascorbic Acid

Condition Name

Condition Name for Ascorbic Acid
Intervention Trials
Sepsis 11
Septic Shock 10
Colonoscopy 7
Pancreatic Cancer 5
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Condition MeSH

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

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

Clinical Trial Status for Ascorbic Acid
Clinical Trial Phase Trials
Completed 115
Recruiting 32
Unknown status 24
[disabled in preview] 18
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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
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Sponsor Type

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


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.


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.

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.

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.

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).

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.

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).


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/

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