Arginine

Evidence Level: L4

Predicted Indications: 1

Arginine

Pharmacist Assessment Report

Arginine: From Unspecified Original Indication to gastroparesis

One-Sentence Summary

Arginine is an amino acid marketed in India as a single-ingredient oral product in several forms (sachets, tablets, capsules, powders). The TxGNN model predicts it may be useful for gastroparesis. However, there are no registered clinical trials and the literature consists of 9 publications, almost all animal or mechanistic studies, so the evidence is early-stage.

Quick Overview

Item	Content
Original Indication	Not stated in the available licence data
Predicted New Indication	Gastroparesis
TxGNN Prediction Score	0.9942
Evidence Level	L4
India Market Status	Listed in a compiled Indian medicine price dataset (11 of 11) – CDSCO approval status is not included in this data
Number of Listed Products	11 (valid: 11)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on known biology, L-arginine is the substrate of neuronal nitric oxide synthase (nNOS), which produces nitric oxide (NO). NO is the main inhibitory neurotransmitter driving nitrergic relaxation of the gastric fundus and pyloric sphincter, and these actions underlie gastric accommodation and emptying.

Loss of nNOS-expressing neurons in the myenteric plexus is a recognised feature of diabetic gastroparesis. A mouse study (PMID 25057793) found that glucocorticoid-induced gastroparesis involved depletion of L-arginine, and suggested that arginine supplementation may reverse it. A Parkinson’s disease rat model (PMID 35380456) with impaired nitrergic relaxation of the pyloric sphincter is consistent with the same pathway.

These findings support biological plausibility only. They come from animal models, and most of the other retrieved papers address gastric motility, neuropathy or electrical stimulation without testing arginine. The high TxGNN score is a computational prediction, not clinical evidence.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
25057793	2014	Animal study (mouse)	Endocrinology	Dexamethasone caused gastroparesis in mice through depletion of L-arginine; the effect depended on the glucocorticoid receptor
35380456	2022	Animal study (rat), mechanistic	Am J Physiol Gastrointest Liver Physiol	Impaired nitrergic relaxation of the pyloric sphincter in a Parkinson’s disease rat model with gastroparesis
18312542	2008	Animal study (rat)	Neurogastroenterol Motil	Myenteric neuropathy and nNOS changes in the jejunum of diabetic BB rats
18322959	2008	Animal study (mouse), not arginine-specific	World J Gastroenterol	Ghrelin and GHRP-6 effects on gastric motility in diabetic mice with gastroparesis
19023028	2009	Animal study (dog), not arginine-specific	Am J Physiol Gastrointest Liver Physiol	Synchronized gastric electrical stimulation improved vagotomy-induced impairment of gastric accommodation via the nitrergic pathway
21193530	2011	Animal study, not arginine-specific	Am J Physiol Gastrointest Liver Physiol	Hyperglycaemia inhibits gastric motility via nodose ganglia KATP channels
31984783	2020	Animal study (rat), not arginine-specific	Am J Physiol Gastrointest Liver Physiol	Sacral nerve stimulation increased gastric accommodation via spinal afferent and vagal efferent pathways
8194696	1994	Animal study (rat)	Gastroenterology	Gastric motor response to food protein-induced anaphylaxis, with delayed gastric emptying
33867519	2021	Case report	Am J Case Rep	Lifestyle changes normalised serum lactate in an m.3243A>G mitochondrial variant carrier; limited relevance to gastroparesis

India Market Information

Licence records do not include approved indication text. The main authorisations are:

Authorization Number	Product Name	Dosage Form	Approved Indication
5598	Argioram Sachet Sugar Free (KRP Pharma)	Sachet of 5 g granules	Not stated
230912	UGR A Softgel Capsule (Zelleven Healthcare)	Packet of 10 vaginal capsules	Not stated
1509	Argifizz 1500mg Tablet (Novelty Healthshine)	Strip of 10 tablets	Not stated
231213	Upgar Powder Lemony Orange Sugar Free (Karisca Healthcare)	Sachet of 10 g powder	Not stated
3873	Arginall 500mg Capsule (Xeno Pharmaceuticals)	Strip of 10 capsules	Not stated

All 11 registrations are valid products, and none are cancelled.

Review correction (2026-11-06): Originally stated: “All 11 registrations are valid single-ingredient products, and none are cancelled.” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.

Safety Considerations

Package insert warnings, contraindications and drug interaction data were not available. Please refer to the package insert for safety information.

The TxGNN knowledge graph links arginine to the following conditions as potential contraindications. These come from graph relationships, not from label text, and should be verified:

Renal and urinary: kidney disease, chronic kidney disease, chronic renal failure, end-stage renal failure, nephrolithiasis, nephrocalcinosis, acute urate nephropathy, pyoureter
Calcium, phosphorus and bone: hypercalcaemia, humoral hypercalcaemia of malignancy, hyperparathyroidism, osteitis fibrosa, sarcoidosis, phosphorus metabolism disease, lytic metastatic bone lesion
Acid-base: metabolic acidosis, renal tubular acidosis, acidosis disorder
Cardiac: heart disease, cardiovascular disease, digitalis poisoning, ventricular fibrillation
Haematological: sickle cell anaemia, hereditary persistence of fetal haemoglobin
Metabolic: phenylketonuria, disorder of phenylalanine metabolism
Gastrointestinal: constipation disorder

Several of these (renal impairment, cardiac disease, and metabolic acidosis) would be common in the diabetic gastroparesis population and need careful assessment.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction is mechanistically plausible through the arginine–nNOS–nitric oxide pathway, but support is limited to animal and mechanistic studies, with no registered clinical trials and no human efficacy data. Label safety information is also missing, and the knowledge graph flags several relevant potential contraindications. The topic is best treated as a research question for now.

To proceed, the following is needed:

Package insert warnings and contraindications from the Indian regulatory source (a blocking gap for safety screening)
Approved indication text for the Indian licences, to establish the original indication
Mechanism of action data from DrugBank
Human evidence, such as a pilot or proof-of-concept study of arginine in gastroparesis (for example, diabetic gastroparesis with measured gastric emptying)
A safety assessment for patients with renal impairment, cardiac disease or acid-base disturbances
Dosage form and route review, since the current products are oral sachets, tablets and capsules, and one is a vaginal capsule

Review Log

Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.

Review date	Item	Action	Source
2026-11-06	Removed: “single-ingredient”	Corrected	Indian Medicine Dataset

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.