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L-tryptophan supplementation
L-tryptophan supplementation is a Amino acid supplement Small molecule drug developed by University of Colorado, Denver. It is currently in Phase 3 development for Depression or mood disorders, Sleep disorders, Anxiety disorders. Also known as: L-tryptophan 1 gm PO TID starting the evening of surgery.
L-tryptophan supplementation increases the availability of tryptophan, an essential amino acid that serves as a precursor for serotonin and other neurotransmitters.
L-tryptophan supplementation increases the availability of tryptophan, an essential amino acid that serves as a precursor for serotonin and other neurotransmitters. Used for Depression or mood disorders, Sleep disorders, Anxiety disorders.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | L-tryptophan supplementation |
|---|---|
| Also known as | L-tryptophan 1 gm PO TID starting the evening of surgery |
| Sponsor | University of Colorado, Denver |
| Drug class | Amino acid supplement |
| Target | Serotonin synthesis pathway (tryptophan hydroxylase substrate) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry/Neurology |
| Phase | Phase 3 |
Mechanism of action
L-tryptophan is converted to serotonin in the brain, which regulates mood, sleep, and other neurological functions. By supplementing dietary tryptophan intake, the drug aims to enhance serotonin synthesis and improve conditions associated with serotonin deficiency. This mechanism may also involve effects on other tryptophan metabolites such as kynurenine pathway products.
Approved indications
- Depression or mood disorders
- Sleep disorders
- Anxiety disorders
Common side effects
- Nausea
- Headache
- Drowsiness
- Gastrointestinal upset
Key clinical trials
- Plant Protein With Ashwagandha-Rhodiola for Sleep Quality (NA)
- A Replicate Crossover Trial on Nutritional Supplementation in Association Football (Soccer) (NA)
- Daily Amino Acid Supplementation for People With Parkinson's Disease (NA)
- Amino Acids in Patients With Anorexia Nervosa: Double-blind Randomized Study Versus Placebo (NA)
- Exploring the Influence of Trptophan on the Treatment of Pouchitis (NA)
- Effects of Daily Supplementation of 5-HTP on Body Composition (NA)
- Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes (NA)
- Oral Supplement and Acute Resistance Exercise (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:
- L-tryptophan supplementation CI brief — competitive landscape report
- L-tryptophan supplementation updates RSS · CI watch RSS
- University of Colorado, Denver portfolio CI
Frequently asked questions about L-tryptophan supplementation
What is L-tryptophan supplementation?
How does L-tryptophan supplementation work?
What is L-tryptophan supplementation used for?
Who makes L-tryptophan supplementation?
Is L-tryptophan supplementation also known as anything else?
What drug class is L-tryptophan supplementation in?
What development phase is L-tryptophan supplementation in?
What are the side effects of L-tryptophan supplementation?
What does L-tryptophan supplementation target?
Related
- Drug class: All Amino acid supplement drugs
- Target: All drugs targeting Serotonin synthesis pathway (tryptophan hydroxylase substrate)
- Manufacturer: University of Colorado, Denver — full pipeline
- Therapeutic area: All drugs in Psychiatry/Neurology
- Indication: Drugs for Depression or mood disorders
- Indication: Drugs for Sleep disorders
- Indication: Drugs for Anxiety disorders
- Also known as: L-tryptophan 1 gm PO TID starting the evening of surgery
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing