Low dose omega-3 fatty acid supplementation

Zhejiang University · Phase 1 active Small molecule Quality 15/100

Low dose omega-3 fatty acid supplementation is a Small molecule drug developed by Zhejiang University. It is currently in Phase 1 development. Also known as: Fish oil supplement.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 1 → approval rate +9.6pp
  Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Low dose omega-3 fatty acid supplementation
Also known as	Fish oil supplement
Sponsor	Zhejiang University
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

• Gastrointestinal
• Infectious
• Psychological
• Nose
• Sleep
• Chest
• Energy
• Ear
• Muscular
• Skin
• Eye
• Genital

Key clinical trials

• Omega-3 Supplementation and Mental Health in College Students (NA)
• Long-Term Omega-3 and Omega-3 Index >8%: Effects on Physiological Recovery (NA)
• Enteral High-dose DHA Supplementation on Bronchopulmonary Dysplasia in Very Preterm Infants: a Collaborative Study (NA)
• Hepatoprotective Measures for Children at High Risk of NAFLD (PHASE4)
• Hepatoprotective for Children and Adolescent With Acute Lymphoblastic Leukemia (PHASE4)
• Effectiveness of Nutrition Education Program and Omega-3 Supplementation Among Non-alcoholic Fatty Liver Disease Patients (NA)
• The Effect of Omega-3 FA on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Patients (NA)
• Omega-3 Fatty Acid Supplementation and Tear Film Quality in Celiac Patients (NA)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Low dose omega-3 fatty acid supplementation CI brief — competitive landscape report
• Low dose omega-3 fatty acid supplementation updates RSS · CI watch RSS
• Zhejiang University portfolio CI

Frequently asked questions about Low dose omega-3 fatty acid supplementation

What is Low dose omega-3 fatty acid supplementation?

Low dose omega-3 fatty acid supplementation is a Small molecule drug developed by Zhejiang University.

Who makes Low dose omega-3 fatty acid supplementation?

Low dose omega-3 fatty acid supplementation is developed by Zhejiang University (see full Zhejiang University pipeline at /company/zhejiang-university).

Is Low dose omega-3 fatty acid supplementation also known as anything else?

Low dose omega-3 fatty acid supplementation is also known as Fish oil supplement.

What development phase is Low dose omega-3 fatty acid supplementation in?

Low dose omega-3 fatty acid supplementation is in Phase 1.

What are the side effects of Low dose omega-3 fatty acid supplementation?

Common side effects of Low dose omega-3 fatty acid supplementation include Gastrointestinal, Infectious, Psychological, Nose, Sleep, Chest.

Related

• Manufacturer: Zhejiang University — full pipeline
• Also known as: Fish oil supplement