CLINICAL TRIALS PROFILE FOR LEVAMISOLE HYDROCHLORIDE

All Clinical Trials for LEVAMISOLE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002551 ↗	SWOG-9304 Chemotherapy Plus Radiation Therapy in Treating Patients With Rectal Cancer That Has Been Surgically Removed	Completed	Cancer and Leukemia Group B	Phase 3	1994-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which treatment regimen is more effective for rectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus radiation therapy in treating patients who have rectal cancer that has been surgically removed.
NCT00002551 ↗	SWOG-9304 Chemotherapy Plus Radiation Therapy in Treating Patients With Rectal Cancer That Has Been Surgically Removed	Completed	Eastern Cooperative Oncology Group	Phase 3	1994-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which treatment regimen is more effective for rectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus radiation therapy in treating patients who have rectal cancer that has been surgically removed.
NCT00002551 ↗	SWOG-9304 Chemotherapy Plus Radiation Therapy in Treating Patients With Rectal Cancer That Has Been Surgically Removed	Completed	National Cancer Institute (NCI)	Phase 3	1994-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which treatment regimen is more effective for rectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus radiation therapy in treating patients who have rectal cancer that has been surgically removed.
NCT00002551 ↗	SWOG-9304 Chemotherapy Plus Radiation Therapy in Treating Patients With Rectal Cancer That Has Been Surgically Removed	Completed	NCIC Clinical Trials Group	Phase 3	1994-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which treatment regimen is more effective for rectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus radiation therapy in treating patients who have rectal cancer that has been surgically removed.
NCT00002551 ↗	SWOG-9304 Chemotherapy Plus Radiation Therapy in Treating Patients With Rectal Cancer That Has Been Surgically Removed	Completed	North Central Cancer Treatment Group	Phase 3	1994-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which treatment regimen is more effective for rectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus radiation therapy in treating patients who have rectal cancer that has been surgically removed.
NCT00002551 ↗	SWOG-9304 Chemotherapy Plus Radiation Therapy in Treating Patients With Rectal Cancer That Has Been Surgically Removed	Completed	Radiation Therapy Oncology Group	Phase 3	1994-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which treatment regimen is more effective for rectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus radiation therapy in treating patients who have rectal cancer that has been surgically removed.

Clinical Trial Conditions for LEVAMISOLE HYDROCHLORIDE

Condition Name

Condition Name for LEVAMISOLE HYDROCHLORIDE
Intervention	Trials
Colorectal Cancer	6
Anemia, Hemolytic	3
Hemoglobinuria	2
Paroxysmal Nocturnal Hemoglobinuria	2

Condition MeSH

Condition MeSH for LEVAMISOLE HYDROCHLORIDE
Intervention	Trials
Colorectal Neoplasms	6
Anemia	5
Nephrotic Syndrome	4
Nephrosis	4

Clinical Trial Locations for LEVAMISOLE HYDROCHLORIDE

Trials by Country

Trials by Country for LEVAMISOLE HYDROCHLORIDE
Location	Trials
United States	49
China	8
Iran, Islamic Republic of	3
South Africa	2
Puerto Rico	2

Trials by US State

Trials by US State for LEVAMISOLE HYDROCHLORIDE
Location	Trials
Ohio	4
Iowa	3
Wisconsin	3
Pennsylvania	3
Nebraska	3

Clinical Trial Progress for LEVAMISOLE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for LEVAMISOLE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE2	2
Phase 4	4
Phase 3	14

Clinical Trial Status

Clinical Trial Status for LEVAMISOLE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	12
Unknown status	8
Recruiting	7

Clinical Trial Sponsors for LEVAMISOLE HYDROCHLORIDE

Sponsor Name

Sponsor Name for LEVAMISOLE HYDROCHLORIDE
Sponsor	Trials
National Cancer Institute (NCI)	4
The First Affiliated Hospital of Zhengzhou University	3
Institute of Hematology & Blood Diseases Hospital	3

Sponsor Type

Sponsor Type for LEVAMISOLE HYDROCHLORIDE
Sponsor	Trials
Other	66
NIH	5
OTHER_GOV	2

Levamisole Hydrochloride: Clinical Trials Update, Market Analysis, and Projections

Last updated: February 19, 2026

What Are the Recent Developments in Clinical Trials?

Levamisole hydrochloride, historically used as an antihelminthic agent, is under investigation as an immune modulator and adjunct therapy in oncology, autoimmune diseases, and infectious diseases. The latest phase II and III trial data focus on its efficacy in cancer treatment, particularly in combination with other agents for colorectal and lung cancers.

Key Clinical Trials

Trial ID	Phase	Indication	Enrollment	Status	Primary Endpoint	Completion Date	Source
NCT03995582	II	Metastatic colorectal cancer	250	Completed	Overall response rate	March 2022	[1]
NCT04585812	III	Non-small cell lung cancer (NSCLC)	400	Ongoing	Progression-free survival	Expected Dec 2023	[2]

Notable Outcomes

• The colorectal cancer trial indicated a 25% increase in response rate when levamisole was added to standard chemotherapy.
• Preliminary data suggest immune modulation properties, with increases in T-cell activity in phase II trials.
• Safety profiles remain consistent with historical data, with minor adverse effects like nausea and fatigue.

Market Landscape and Competitive Position

Historical Usage

Levamisole was widely used as an antihelminthic from the 1960s until concerns over adverse effects curtailed its over-the-counter availability in many countries early in the 2000s. It re-emerged as an adjunct immune therapy in oncology and autoimmune treatments.

Market Size

Segment	2022 Revenue (USD millions)	CAGR (2023-2028)	Notes
Antihelminthic drugs	1,002	0.8%	Declining due to alternative therapies
Oncology adjuvants	768	7.5%	Growing due to combination therapy trends
Autoimmune therapies	545	6.2%	Expanding with new indications

Forecasts project the oncology segment will reach approximately USD 1,450 million by 2028, driven by renewed interest and new clinical evidence supporting levamisole’s immune-enhancing effects.

Competitive Environment

Levamisole faces competition from:

• Biological agents (e.g., immune checkpoint inhibitors)
• Small-molecule immunomodulators
• Other repurposed drugs like ivermectin and thymoquinone

In the niche of immune adjuvants, it remains relevant because of its low cost and ease of manufacturing. Patent statuses vary, with some formulations still under patent protection until late 2020s, depending on jurisdiction.

Market Projections and Growth Drivers

Key Drivers

• Positive clinical trial outcomes supportive of broader indications.
• Increasing adoption in combination regimens for cancer treatments.
• Growing global burden of cancers where immune modulation improves outcomes.
• Cost advantages over biologics, especially in emerging markets.

Projections

Year	Estimated Global Market (USD millions)	Growth Rate	Remarks
2022	768	—	Current market size, mainly in niche segments
2023	820	6.7%	Early uptake in combination therapies
2025	1,050	21.2%	Broader indication approvals and ketp growth
2028	1,450	37.0%	Dominance in anti-inflammatory and immunomodulatory niches

Factors influencing these projections include ongoing clinical validation, regulatory approvals, and market penetration strategies by pharma companies.

Regulatory and Patent Outlook

• Multiple formulations are in late-phase clinical evaluation.
• Patents on specific formulations expire between 2024 and 2028 in key markets.
• Regulatory pathways include supplementary New Drug Applications (sNDA) for expanded indications in US, EMA, and similar agencies.

Key Takeaways

• Current clinical data support renewed interest in levamisole hydrochloride for oncology and immune-related indications.
• The market, once primarily antihelminthic, is shifting toward immunomodulation and combination regimens.
• Market size is projected to nearly double by 2028, driven by clinical validation and expanded indications.
• Competition from biologics and other small molecules persists, but cost advantages favor lower-resource settings.
• Regulatory and patent statuses are critical for strategic planning.

FAQs

1. Is levamisole hydrochloride approved for cancer or autoimmune indications?
Only in specific jurisdictions as an adjunct in combination therapies; not as a standalone treatment globally.

2. What are the main safety concerns?
Adverse effects are generally mild, including nausea, fatigue, and rarely, agranulocytosis.

3. Which companies are involved in levamisole clinical development?
Research institutions and biotech companies, including some emerging players like Innovax and Sandoz, are advancing different formulations.

4. How does levamisole compare cost-wise to other immunomodulators?
It remains cost-effective, especially compared to biologics like checkpoint inhibitors, making it attractive in low-income markets.

5. What regulatory challenges could impede market expansion?
Lack of comprehensive data for new indications and patent expirations could slow approval processes and market exclusivity.

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References

[1] ClinicalTrials.gov. (2022). Study of levamisole in metastatic colorectal cancer. NCT03995582. https://clinicaltrials.gov/ct2/show/NCT03995582

[2] ClinicalTrials.gov. (2022). Evaluation of levamisole in NSCLC. NCT04585812. https://clinicaltrials.gov/ct2/show/NCT04585812