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Condition (MeSH)

Serotonin Syndrome

ClinicalTrials.gov lists 35 trials for Serotonin Syndrome or a narrower condition beneath it. Lexicon Pharmaceuticals has the most among industry and government lead sponsors, with 6.

MeSH D020230 Chemically-Induced Disorders C25 Listed by Orphanet as a rare disease
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Phase 1 Phase 1 2 Phase 1/2 Phase 1/2 1 Phase 2 Phase 2 13 Phase 3 Phase 3 8 Phase 4 Phase 4 1 Not applicable Not applicable 2 Observational Observational 8 Phase 1 Phase 1 2 Phase 1/2 Phase 1/2 1 Phase 2 Phase 2 13 Phase 3 Phase 3 8 Phase 4 Phase 4 1 Not applicable Not applicable 2 Observational Observational 8

Trials per phase

35 of the 35 trials are tagged with Serotonin Syndrome itself; the rest are tagged with a narrower condition beneath it.

Get the Serotonin Syndrome report as a PDF

The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Serotonin Syndrome trials start? (17)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational

Top of scale: 4

2004: 2 trials (Phase 3 1, Phase 2 1) 2008: 1 trials (Observational 1) 2009: 4 trials (Observational 1, Phase 3 1, Phase 2 1, Phase 1/2 1) 2010: 3 trials (Observational 1, Phase 2 2) 2011: 2 trials (Observational 2) 2013: 3 trials (Phase 3 1, Phase 2 1, Phase 1 1) 2014: 2 trials (Phase 3 2) 2015: 2 trials (Phase 2 1, Phase 1 1) 2016: 1 trials (Phase 4 1) 2017: 1 trials (Observational 1) 2018: 2 trials (Phase 2 2) 2019: 1 trials (Not applicable 1) 2020: 2 trials (Phase 3 1, Phase 2 1) 2021: 4 trials (Phase 3 1, Phase 2 3) 2022: 3 trials (Observational 1, Not applicable 1, Phase 2 1) 2025: 1 trials (Phase 3 1)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 1
2025 1
2022 3
2021 4
2020 2
2019 1
2018 2
2017 1
2016 1
2015 2

No forecast is made for this condition: it averages 1.0 trial starts a year over the five years to September, under the 5 a year the method needs.

Recruitment duration, a model prediction: 1 trial still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Serotonin Syndrome trials in? (7)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 2
Phase 1/2 1
Phase 2 13
Phase 3 8
Phase 4 1
Not applicable 2
Observational 8

How many Serotonin Syndrome trials are recruiting? (7)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 1
Recruiting 1
Active, not recruiting 2
Completed 18
Terminated 5

Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Serotonin Syndrome trials? (6)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
Lexicon Pharmaceuticals 6
Ipsen 4
Crinetics Pharmaceuticals Inc. 2
Camurus AB 1
Endo USA Inc., a Keenova Therapeutics Company 1

Which drugs are being tested for Serotonin Syndrome? (3)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
Telotristat Etiprate 7
Telotristat Ethyl 3
Cyproheptadine 2

Interventions as named in the registry (12)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
LAR Octreotide 2
LAR Lanreotide 2
500 mg [14C]-LX1606 1
Randomized: 80 mg Paltusotine 1
Lutetium-177 DOTATATE 1

These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Serotonin Syndrome trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Disease progression 18 4
Small intestinal obstruction 11 5
Abdominal pain 9 3
Investigation 9 2
Neuroendocrine tumour 8 3

Which publications cover Serotonin Syndrome? (11)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
5-Hydroxytryptophan (5-HTP): Natural Occurrence, Analysis, Biosynthesis, Biotechnology, Physiology and Toxicology. International journal of molecular sciences 2020 Yes
Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis. Clinical therapeutics 2016 Yes
Tramadol, Pharmacology, Side Effects, and Serotonin Syndrome: A Review. Pain physician 2015 Yes
Serotonin syndrome in a patient taking Lexapro and Flexeril: a case report. The American journal of emergency medicine 2008 Yes
Serotonin toxicity associated with the use of linezolid: a review of postmarketing data. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 2006 Yes

Prevalence (3)

Shown in this order: jurisdiction, then disease name. Orphanet observation for the mapped ORPHA concept; the mapping relation column says whether that concept is exactly this condition or broader or narrower.

Prevalence
Orphanet disease Type Class Geography Jurisdiction Mapping relation
Serotonin syndrome Point prevalence Unknown Worldwide Not stated Unspecified
Serotonin syndrome Point prevalence Unknown Worldwide Not stated Exact
Serotonin syndrome Point prevalence Unknown Worldwide Not stated Exact

Rare-disease identity (2)

Shown in this order: exact, broader, narrower, other.

Rare-disease identity
Orphanet disease ORPHA code Relation Source
Serotonin syndrome 43116 Exact Orphanet Rare Disease Ontology (ORDO)
Serotonin syndrome 43116 Exact Orphadata Science knowledge files, Product 1

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: sub-conditions in mesh.

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