> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/fish-oil-ad06c0e1-eb05-4af3-8ddc-aeba0adf11fd
> Record changed: 2026-10-13

# FISH OIL

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833369)

Drug type

Unknown

First approval year

2016

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833369)

## Development status

**First approval year**

2016

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833369)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833369)

## Names and chemistry

**Drug type**

Unknown

**Drug name**

FISH OIL

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833369)

### Other names (28)

- b1782
- B1782
- fish oil
- Fish oil
- Fish Oil (Containing Omega-3 Acids)
- fish oil (FO)-containing IVFE (Lipidem)
- Fish oil (Maxepa)
- FISH OIL \[ORANGE BOOK\]
- FISH OIL \[USP-RS\]
- FISH OIL \[VANDF\]
- Fish oil \[WHO-DD\]
- Fish oil concentrate
- fish oil containing omega 3 acids
- fish oil containing omega 3 acids dsc
- FISH OIL CONTAINING OMEGA-3 ACIDS \[DSC\]
- fish oil fo containing ivfe lipidem
- fish oil orange book
- fish oil usp rs
- fish oil vandf
- fish oil who dd
- Fish oil-containing total parenteral nutrition (PN)
- fish oils
- Fish oils
- FISH OILS
- omega 3 fish oil

And 3 more, listed on the interactive page.

## Identifiers

**ChEMBL ID**

CHEMBL3833369

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833369)

**RxNorm IDs (RxCUI)**

- 4419

**FDA ingredient codes (UNII)**

- XGF7L72M0F

## Regulatory information

### United States

**Applicant**

FRESENIUS KABI USA

**Approval date**

13 Jul 2016

**Application number**

NDA207648

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

#### Administration routes

- Parenteral

### Investigated indications (25)

- **Condition**  
Cardiovascular Diseases

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000319

**Subject identifier**  
D002318
- **Condition**  
Epilepsy

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000474

**Subject identifier**  
D004827
- **Condition**  
Arthritis, Rheumatoid

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000685

**Subject identifier**  
D001172
- **Condition**  
Obesity

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0001073

**Subject identifier**  
D009765
- **Condition**  
Liver Diseases

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0001421

**Subject identifier**  
D008107
- **Condition**  
Coronary Disease

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0001645

**Subject identifier**  
D003327
- **Condition**  
Kidney Diseases

**Highest recorded phase**

0.5

**Condition identifier**  
EFO:0003086

**Subject identifier**  
D007674
- **Condition**  
Non-alcoholic Fatty Liver Disease

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003095

**Subject identifier**  
D065626
- **Condition**  
Renal Insufficiency, Chronic

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003884

**Subject identifier**  
D051436
- **Condition**  
Intestinal Diseases

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0009431

**Subject identifier**  
D007410
- **Condition**  
Brain Concussion

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0011023

**Subject identifier**  
D001924
- **Condition**  
Aging

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0022597

**Subject identifier**  
D000375
- **Condition**  
Diabetic Neuropathies

**Highest recorded phase**  
1

**Condition identifier**  
EFO:1000783

**Subject identifier**  
D003929
- **Condition**  
Phobia, Social

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1001917

**Subject identifier**  
D000072861
- **Condition**  
Fatty Liver

**Highest recorded phase**  
2

**Condition identifier**  
HP:0001397

**Subject identifier**  
D005234
- **Condition**  
Cholestasis

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0001751

**Subject identifier**  
D002779
- **Condition**  
Depressive Disorder, Major

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0002009

**Subject identifier**  
D003865
- **Condition**  
Depressive Disorder

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0002050

**Subject identifier**  
D003866
- **Condition**  
Asthma

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0004979

**Subject identifier**  
D001249
- **Condition**  
Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0004992

**Subject identifier**  
D009369
- **Condition**  
Multiple Sclerosis

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0005301

**Subject identifier**  
D009103
- **Condition**  
Breast Neoplasms

**Highest recorded phase**

0.5

**Condition identifier**  
MONDO:0007254

**Subject identifier**  
D001943
- **Condition**  
Lupus Erythematosus, Systemic

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0007915

**Subject identifier**  
D008180
- **Condition**  
Inflammation

**Highest recorded phase**  
2

**Condition identifier**  
MP:0001845

**Subject identifier**  
D007249
- **Condition**  
Lipid Metabolism Disorders

**Highest recorded phase**  
3

**Condition identifier**  
Orphanet:309005

**Subject identifier**  
D052439

### Open Targets indications (68)

- **Condition identifier**  
EFO\_0000195
- **Condition identifier**  
EFO\_0000246

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000319

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000474

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000685

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0001073

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0003095
- **Condition identifier**  
EFO\_0004278

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0009431

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0011023

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0022597

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_1000653
- **Condition identifier**  
EFO\_1000783
- **Condition identifier**  
EFO\_1001917

**Highest recorded phase**  
2
- **Condition identifier**  
GO\_0006954

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0000155

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0000458

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0000739

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0000855

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0001397
- **Condition identifier**  
HP\_0001824

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0002019
- **Condition identifier**  
HP\_0002032

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0004308

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0004326

**Highest recorded phase**  
2

And 43 more, listed on the interactive page.

### Reported adverse events (37)

- **Event**  
angina pectoris

**Reports**  
31

**Reporting signal score**

40.2418
- **Event**  
arteriogram coronary

**Reports**  
24

**Reporting signal score**

143.78
- **Event**  
bacillus bacteraemia

**Reports**  
3

**Reporting signal score**

16.3745
- **Event**  
blood triglycerides increased

**Reports**  
43

**Reporting signal score**

90.6745
- **Event**  
cataract

**Reports**  
28

**Reporting signal score**

30.1549
- **Event**  
chest pain

**Reports**  
56

**Reporting signal score**

26.1366
- **Event**  
child abuse

**Reports**  
5

**Reporting signal score**

25.63
- **Event**  
cholestasis

**Reports**  
15

**Reporting signal score**

24.043
- **Event**  
coma

**Reports**  
101

**Reporting signal score**

203.937
- **Event**  
diabetic retinal oedema

**Reports**  
4

**Reporting signal score**

15.1824
- **Event**  
drug hypersensitivity

**Reports**  
34

**Reporting signal score**

15.5546
- **Event**  
dysgeusia

**Reports**  
29

**Reporting signal score**

24.8962
- **Event**  
eructation

**Reports**  
24

**Reporting signal score**

59.2773
- **Event**  
fatty acid deficiency

**Reports**  
34

**Reporting signal score**

231.494
- **Event**  
gastrooesophageal reflux disease

**Reports**  
103

**Reporting signal score**

197.433
- **Event**  
hernia

**Reports**  
21

**Reporting signal score**

41.9303
- **Event**  
hernial eventration

**Reports**  
6

**Reporting signal score**

28.4742
- **Event**  
hypertriglyceridaemia

**Reports**  
17

**Reporting signal score**

32.5478
- **Event**  
infectious mononucleosis

**Reports**  
7

**Reporting signal score**

22.8174
- **Event**  
lactobacillus infection

**Reports**  
3

**Reporting signal score**

15.3908
- **Event**  
lactobacillus test positive

**Reports**  
4

**Reporting signal score**

23.9996
- **Event**  
malassezia infection

**Reports**  
3

**Reporting signal score**

19.4272
- **Event**  
multiple lentigines syndrome

**Reports**  
4

**Reporting signal score**

25.5389
- **Event**  
neoplasm

**Reports**  
13

**Reporting signal score**

23.6923
- **Event**  
pantoea agglomerans infection

**Reports**  
3

**Reporting signal score**

17.8501

And 12 more, listed on the interactive page.

### Trial references (28)

- NCT00047983  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00047983)
- NCT00072982  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00072982)
- NCT00336908  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00336908)
- NCT00392717  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00392717)
- NCT00447291  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00447291)
- NCT00485615  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00485615)
- NCT00511810  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00511810)
- NCT00516178  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00516178)
- NCT00655525  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00655525)
- NCT00658476  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00658476)
- NCT00711971  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00711971)
- NCT00681408  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00681408)
- NCT01547910  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01547910)
- NCT00871377  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00871377)
- NCT01769092  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01769092)
- NCT01057615  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01057615)
- NCT05613803  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05613803)
- NCT01194063  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01194063)
- NCT02420496  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02420496)
- NCT01259284  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01259284)
- NCT02021513  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02021513)
- NCT02178410  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02178410)
- NCT02538484  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02538484)
- NCT02550860  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02550860)
- NCT02939079  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02939079)

And 3 more, listed on the interactive page.

## Dosing

**Dose**

1 capsule

**Route**

Oral

**How often**

Once daily

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

## National Drug Codes

- 63323-205
- 63323-820

## Related records

### Trials (97)

- A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss
- A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)
- A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients
- A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
- A Study of the Effect of Gemcitabine With Fish Oil in Patients With Advanced Pancreatic Cancer
- A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis
- A Study to Determine Optimal Absorption of Single Dose Omega-3
- Cancer Lipidome Adaptation and Resculping Through Omega-3 PUFAs in Breast Tumors
- Comparison of EPA and DHA-Rich Fish Oils on Lipoprotein Metabolism In Adults
- COVID-19 Anosmia Study
- Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis
- Derivatives of Omega-3 HUFA as Biomarkers of Traumatic Brain Injury
- Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)
- Dietary Supplementation With Omega-3 Fatty Acid in Muscle Response
- Does Fish Oil Prevent Depression in Pregnancy and Postpartum?
- Effect of Dietary Supplements With Fish Oil on Mannitol-induced Airway Sensitivity & Inflammation in Persons With Asthma
- Effect of Fish Oil on Adiposity and Atherogenic Factors in Type 2 Diabetic Women
- Effect of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients
- Effect of Omega-3 Fatty Acid on Neurobehavioral Status of Children With Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Trial
- Effect of Omega-3 Fatty Acid on Vitamin D Activation

### In development for (22)

- [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Phase 3
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Early phase 1
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 2
- [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md) Phase 3
- Cholestasis Phase 3
- [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) Phase 2
- [Coronary artery disorder](https://trialight.com/data/condition/coronary-artery-disorder-6f736849-d477-587a-b3fa-b0621d573407.md) Phase 3
- [Depressive disorder](https://trialight.com/data/condition/depressive-disorder-7618feda-3f90-5521-94e1-99f7100e8324.md) Phase 3
- Diabetic neuropathy Phase 1
- Epilepsy Phase 2
- Fatty liver disease Phase 2
- Inherited lipid metabolism disorder Phase 3
- Intestinal disorder Phase 3
- [Kidney disorder](https://trialight.com/data/condition/kidney-disorder-e50371fe-f1a7-53fe-9cfb-9d6da9130e3c.md) Early phase 1
- [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 2
- [Major depressive disorder](https://trialight.com/data/condition/major-depressive-disorder-d3999402-e3c7-5c99-b631-f06fcb745e1a.md) Phase 2
- [Metabolic dysfunction-associated steatotic liver disease](https://trialight.com/data/condition/metabolic-dysfunction-associated-steatotic-liver-disease-beb92cb4-74bc-5e17-96f1-97aeed54ab35.md) Phase 2
- [Multiple sclerosis](https://trialight.com/data/condition/multiple-sclerosis-62806c95-fe1b-529e-bd16-95cb92d15375.md) Phase 2
- [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Phase 3
- [Rheumatoid arthritis](https://trialight.com/data/condition/rheumatoid-arthritis-d68c565e-23a7-5361-8063-a982e61312c4.md) Phase 3

### Other linked conditions (1)

- [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md)

---

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