TheraRadar
Data updated: May 26, 2026

SYNDROS (dronabinol)

CNS Approved 2016-07-01
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
9
Years on Market

Details

Status
Discontinued
First Approved
2016-07-01
Patent Cliff
2028

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Routes
ORAL
Dosage Forms
SOLUTION

Companies

WELLHOUSE PHARMA
Active Ingredient: DRONABINOL

SYNDROS Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2016 to 2024
May 2024 SUPPL
Label · Labeling
FDA Letter Label
Sep 2022 SUPPL
Label · Labeling
FDA Letter Label
Mar 2021 SUPPL
Label · Labeling
FDA Letter Label

What SYNDROS Treats

1 FDA approvals

Originally approved for its first indication in 2016 .

  • Other (1)
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Clinical Trial Registry

30 trials
Trial Sponsor ID Phase Status Title
NCT07231965 25-008291 Ph 2, Ph 3 not yet recruiting Synthetic THC And Blood Pressure
NCT07225777 Pro00148223 K12DA031794 Ph 2 recruiting Sex Differences in Neurobehavioral Response to THC
NCT04374773 PrECEPT results posted STUDY00008064 2P01DA032507-06A1 Ph 4 completed Effects of Pregnancy-associated Hormones on THC Metabolism in Women
NCT07570953 25-009764 Ph 2, Ph 3 not yet recruiting A Study Of Synthetic THC And Sleep
NCT06454669 DARP H-51389 Ph 2 recruiting Dronabinol as an Adjunct for Reducing Pain
NCT05865470 SAGE 22-001292 R01DA057252 Ph 1 recruiting Age-dependent Effects of Smoked and Oral Delta-9-THC
NCT01964404 results posted D14061 1R01DA034699-01A1 Ph 1 completed Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?
NCT06731894 24435 NCI-2024-08847, 24435 Ph 2 recruiting Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors
NCT05519111 CRISP GCO 22-1141 K23HL151884 Ph 2 recruiting Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain
NCT06477952 DROSA PULM-011-23F Ph 1, Ph 2 recruiting DRonabinol Treatment of OSA
NCT05820685 DOPE results posted HSC-MS-22-0499 Ph 4 terminated Dronabinol On the Pain Experience
NCT02811510 THC-Gender-I 1505015940.A Ph 1 recruiting Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I
NCT05335252 STU00213383 Ph 3 recruiting Dronabinol After Arthroscopic Surgery
NCT06146101 REPOSA IHL42XOSAP2/3 U1111-1302-4915 Ph 2, Ph 3 active not recruiting RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA
NCT05612711 1I01CX002671 Ph 2 withdrawn Dronabinol for Agitation in Dementia Crossover Trial
NCT02460692 results posted 1R01DA038634-01A1 R01DA038634 Ph 2 completed Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain
NCT01093976 results posted 0909M72088 Ph 2 completed Marinol in Trichotillomania or Obsessive Compulsive Disorder
NCT04155008 results posted 2019-10218 Ph 4 terminated Nutrition and Pharmacological Algorithm for Oncology Patients Study
NCT03530800 results posted IRB18-0542 Ph 2, Ph 3 completed Dronabinol in Trichotillomania and Other Body Focused Repetitive Behaviors
NCT01755091 PACE results posted 2012-0095 UM1HL112856 Ph 2 completed Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea
NCT00946348 results posted R01DA013196 1R01DA026799-01, R01DA013196 Ph 1 completed Cannabis and Schizophrenia: Self-Medication and Agonist Treatment
NCT00553059 results posted 2006-0841 MDA-2006-0841, CDR0000573510 Ph 3 completed Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer
NCT02569073 ICAMP 22894 Ph 4 withdrawn Investigation of Cannabinoid Receptor Agonist Dronabinol in Patients With Functional Chest Pain
NCT02608931 14-01577 Ph 2 withdrawn The Safety, Tolerability and Efficacy of Dronabinol, for the Treatment of Nausea and Vomiting in Familial Dysautonomia
NCT01020019 D-LUCS results posted #6015 P50DA009236-16 Ph 2, Ph 3 completed Combined Pharmacotherapy for Cannabis Dependency
NCT01598896 DCCS results posted 2010P-002262 Brain and Behavior Research Ph 2, Ph 3 terminated Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia
NCT02472847 results posted 2012-0242 R21MH093917 Ph 4 completed Cannabinoid Control of Fear Extinction Neural Circuits in Humans
NCT00760695 033 Ph 3 completed Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa
NCT01253408 results posted 08-008314 Part A R01DK079866, UL1RR024150 Ph 2 completed Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS)
NCT01786109 results posted 08-008314 Part B R01DK079866, UL1RR024150 Ph 2 completed Effect of a Cannabinoid Agonist on Colonic Sensory Functions in Patients With Irritable Bowel Syndrome
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

SYNDROS FDA Label Details

View full patent landscape →
4 OB patents · 4 families · 9 international docs across 1 countries

SYNDROS Patents & Exclusivity

Latest Patent: Aug 2028

Patents (4 active)

US10265293 Expires Aug 6, 2028
US9345771 Expires Aug 6, 2028
US11253472 Expires Aug 6, 2028
US8222292 Expires Aug 6, 2028
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2028
  • • 4 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA205525 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.