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Fibromyalgia

46
Pipeline Programs
30
Companies
50
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
5
1
7
1
26
6
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
2100%
+ 97 programs with unclassified modality

On Market (1)

Approved therapies currently available

Eli Lilly and Company
CYMBALTAApproved
duloxetine hydrochloride
Eli Lilly and Company
oral2004

Competitive Landscape

42 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
23 programs
2
1
1
13
3
PregabalinPhase 41 trial
PregabalinPhase 41 trial
pregabalinPhase 41 trial
EsreboxetinePhase 32 trials
PregabalinPhase 31 trial
+18 more programs
Active Trials
NCT00819624Completed185Est. Mar 2009
NCT01203865Unknown1,200Est. Mar 2012
NCT01280747Terminated42Est. Apr 2012
+21 more trials
Prevail Therapeutics
10 programs
7
2
DuloxetinePhase 41 trial
duloxetine hydrochloridePhase 41 trial
DuloxetinePhase 31 trial
DuloxetinePhase 31 trial
DuloxetinePhase 31 trial
+5 more programs
Active Trials
NCT00725101Completed1,700Est. Apr 2011
NCT01237587Completed184Est. Nov 2017
NCT01621191Completed149Est. Feb 2014
+7 more trials
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
4 programs
1
Treatment for FibromyalgiaN/A
DuloxetinePHASE_3
DuloxetinePHASE_3
CYMBALTA(duloxetine)PHASE_3
Oregon Therapeutics
2 programs
1
GabapentinPhase 31 trial
8-form Yang-style Tai chiN/A1 trial
Active Trials
NCT01311427Completed99Est. Jul 2008
NCT01107574Completed41Est. Apr 2010
Syneos Health
2 programs
1
DS-5565Phase 31 trial
The Savella Pregnancy RegistryN/A1 trial
Active Trials
NCT01026077Terminated350Est. Oct 2024
NCT02496884Completed56Est. Jul 2017
Shionogi
ShionogiJapan - Osaka
2 programs
2
DuloxetinePhase 3
Duloxetine 60 mgPhase 3
Marius Pharmaceuticals
1 program
1
CannabidiolPhase 31 trial
Active Trials
NCT04729179Completed200Est. Feb 2024
Axsome Therapeutics
Axsome TherapeuticsNY - New York
1 program
1
esreboxetinePhase 3
Astellas
AstellasChina - Shenyang
2 programs
2
ASP0819Phase 21 trial
ASP8062Phase 21 trial
Active Trials
NCT03056690Completed186Est. Feb 2018
NCT03092726Completed183Est. Mar 2018
MSD
MSDIreland - Ballydine
1 program
1
Ibutamoren MesylatePhase 21 trial
Active Trials
NCT00116129Completed64Est. Apr 2008
Sharp Therapeutics
1 program
1
Ibutamoren MesylatePhase 2
Ono Pharmaceutical
1 program
1
ONO-1110Phase 21 trial
Active Trials
NCT06752590Active Not Recruiting160Est. Sep 2026
Theravance Biopharma
1 program
1
TD-9855 Group 1Phase 21 trial
Active Trials
NCT01693692Completed392Est. Apr 2014
Linnaeus Therapeutics
1 program
1
Mecobalamin 5 MGPhase 1/21 trial
Active Trials
NCT05008042Completed40Est. Mar 2024
Alliance Pharmaceuticals
4 programs
2
HRG 80 Red GinsengPhase 11 trial
Smart Energy SystemPhase 11 trial
Recovery FactorsN/A1 trial
Recovery FactorsN/A1 trial
Active Trials
NCT04381793Completed43Est. Jul 2020
NCT04381780Completed100Est. Jan 2021
NCT04599348Unknown70Est. Apr 2021
+1 more trials
Lundbeck
LundbeckDenmark - Copenhagen
1 program
1
Lu AG06466Phase 11 trial
Active Trials
NCT04974359Terminated3Est. Jan 2022
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
5 programs
pramipexole ERPHASE_21 trial
DuloxetinePHASE_3
DuloxetinePHASE_3
duloxetinePHASE_3
duloxetine hydrochloridePHASE_4
Active Trials
NCT00689052Terminated61
Tonix Pharmaceuticals
Tonix PharmaceuticalsBERKELEY HEIGHTS, NJ
5 programs
TNX-102 SLPHASE_31 trial
TNX-102 SLPHASE_31 trial
TNX-102 SL Tablet, 2.8 mgPHASE_31 trial
TNX-102 SL Tablet, 2.8mgPHASE_31 trial
TNX-102 SL Tablet, 5.6 mgPHASE_31 trial
Active Trials
NCT04508621Completed514Est. Nov 2021
NCT04172831Completed503Est. Oct 2020
NCT02829814Terminated51Est. Sep 2016
+2 more trials
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
4 programs
XyremPHASE_21 trial
Sodium OxybatePHASE_31 trial
Xyrem®PHASE_31 trial
Xyrem®PHASE_31 trial
Active Trials
NCT00087555Completed195Est. Jan 2006
NCT00803023Completed129
NCT00371137Completed548Est. Dec 2008
+1 more trials
Providence Therapeutics
2 programs
Affective Self-Awareness workshopN/A1 trial
Stress and EmotionsPHASE_21 trial
Active Trials
NCT00437411Completed66Est. Nov 2008
NCT01287481Completed230Est. Jul 2015
Trace Biosciences
2 programs
Interoceptive accuracy measurementN/A1 trial
Interoceptive accuracy measurementN/A1 trial
Active Trials
NCT05907590Unknown52Est. Dec 2023
NCT05907538Unknown84Est. Jun 2024
Verona Pharma
Verona PharmaUK - London
2 programs
LIMFA Therapy®N/A1 trial
micronized and ultra-micronized PalmitoylethanolamidePHASE_41 trial
Active Trials
NCT03503760Completed48Est. Jul 2017
NCT04488926Completed21Est. May 2022
UCB Pharma
2 programs
LevetiracetamN/A1 trial
rozanolixizumabPHASE_2Monoclonal Antibody1 trial
Active Trials
NCT00254657Completed66Est. Apr 2005
NCT05643794Completed63Est. Jul 2024
Sana Health
2 programs
Sana DeviceN/A1 trial
Sana Sham DeviceN/A1 trial
Active Trials
NCT05394610Withdrawn0Est. Jun 2027
NCT04568798Completed166Est. Mar 2022
Radiance Biopharma
1 program
Active PBMTN/A1 trial
Active Trials
NCT04322812Completed90Est. Oct 2020
Cefaly
1 program
CefalyN/A1 trial
Active Trials
NCT02546362Completed50Est. May 2018
Neurotech Pharmaceuticals
1 program
DSF-rTMSN/A1 trial
Active Trials
NCT01229852Completed35Est. Oct 2011
Theranica
TheranicaNJ - Bridgewater
1 program
FibroNovaN/A1 trial
Active Trials
NCT06271746Unknown170Est. Jun 2025
Walden Biosciences
1 program
Laughter FrequencyN/A1 trial
Active Trials
NCT02957110Completed41Est. Oct 2017
Human BioSciences
1 program
Lifestyle CountsN/A1 trial
Active Trials
NCT00596674Completed177Est. May 2008

+12 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Verona Pharmamicronized and ultra-micronized Palmitoylethanolamide
PfizerPregabalin
Pfizerpregabalin
PfizerPregabalin
Prevail TherapeuticsDuloxetine
Prevail Therapeuticsduloxetine hydrochloride
Eisaizonisamide
Tonix PharmaceuticalsTNX-102 SL Tablet, 5.6 mg
Marius PharmaceuticalsCannabidiol
Tonix PharmaceuticalsTNX-102 SL
Tonix PharmaceuticalsTNX-102 SL
Tonix PharmaceuticalsTNX-102 SL Tablet, 2.8 mg
Syneos HealthDS-5565
Tonix PharmaceuticalsTNX-102 SL Tablet, 2.8mg
Prevail TherapeuticsDuloxetine

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 15,631 patients across 50 trials

NCT04488926Verona Pharmamicronized and ultra-micronized Palmitoylethanolamide

Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

Start: Jul 2020Est. completion: May 202221 patients
Phase 4Completed
NCT01397006PfizerPregabalin

Fibromyalgia of Less Than One Year Duration. Study of Pregabalin

Start: Sep 2011Est. completion: Mar 20140
Phase 4Withdrawn
NCT01020526Pfizerpregabalin

Pregabalin In Adolescent Patients With Fibromyalgia

Start: Sep 2010Est. completion: Jun 201563 patients
Phase 4Completed
NCT01226667PfizerPregabalin

Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia

Start: Jul 2010Est. completion: Jul 2012174 patients
Phase 4Completed
NCT01089621Prevail TherapeuticsDuloxetine

A Study for Adolescents With Fibromyalgia Syndrome

Start: Mar 2010Est. completion: Aug 20100
Phase 4Withdrawn
NCT00673452Prevail Therapeuticsduloxetine hydrochloride

A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia

Start: Jun 2008Est. completion: Jul 2009530 patients
Phase 4Completed
NCT00259636Eisaizonisamide

Zonisamide for Fibromyalgia & Migraine

Start: Aug 2004Est. completion: Jan 20080
Phase 4Withdrawn
NCT05273749Tonix PharmaceuticalsTNX-102 SL Tablet, 5.6 mg

A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia

Start: Apr 2022Est. completion: Nov 2023457 patients
Phase 3Completed
NCT04729179Marius PharmaceuticalsCannabidiol

Cannabidiol for Fibromyalgia (The CANNFIB Trial)

Start: Mar 2021Est. completion: Feb 2024200 patients
Phase 3Completed
NCT04508621Tonix PharmaceuticalsTNX-102 SL

A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

Start: Jul 2020Est. completion: Nov 2021514 patients
Phase 3Completed
NCT04172831Tonix PharmaceuticalsTNX-102 SL

A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

Start: Dec 2019Est. completion: Oct 2020503 patients
Phase 3Completed
NCT02829814Tonix PharmaceuticalsTNX-102 SL Tablet, 2.8 mg

Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia

Start: Jul 2016Est. completion: Sep 201651 patients
Phase 3Terminated
NCT02496884Syneos HealthDS-5565

Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease

Start: Jun 2015Est. completion: Jul 201756 patients
Phase 3Completed
NCT02436096Tonix PharmaceuticalsTNX-102 SL Tablet, 2.8mg

A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia

Start: Apr 2015Est. completion: Sep 2016519 patients
Phase 3Completed
NCT01621191Prevail TherapeuticsDuloxetine

An Extension Study of Duloxetine in Fibromyalgia (Extension of F1J-JE-HMGZ, NCT01552057)

Start: Jun 2012Est. completion: Feb 2014149 patients
Phase 3Completed
NCT01552057Prevail TherapeuticsDuloxetine 60 mg

A Study of Duloxetine in Fibromyalgia

Start: Mar 2012Est. completion: Dec 2013393 patients
Phase 3Completed
NCT01387607Pfizerpregabalin

A Study For Pregabalin In Patients With Fibromyalgia

Start: Feb 2012Est. completion: Oct 2016343 patients
Phase 3Completed
NCT01432236PfizerPregabalin

A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

Start: Oct 2011Est. completion: Jul 2013197 patients
Phase 3Completed
NCT01237587Prevail TherapeuticsDuloxetine

A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

Start: Mar 2011Est. completion: Nov 2017184 patients
Phase 3Completed
NCT00803023Jazz PharmaceuticalsSodium Oxybate

Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia

Start: Mar 2010129 patients
Phase 3Completed
NCT00830128Pfizerpregabalin

A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia

Start: Jul 2009Est. completion: Feb 2011106 patients
Phase 3Completed
NCT00883740PfizerPregabalin

Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia

Start: Jun 2009Est. completion: Jun 2010119 patients
Phase 3Completed
NCT00796601PfizerEsreboxetine

Maintenance of Efficacy.

Start: May 2009Est. completion: Nov 20100
Phase 3Withdrawn
NCT00612170Pfizer[S,S]-Reboxetine

A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.

Start: Dec 2007Est. completion: May 20091,129 patients
Phase 3Completed
NCT00607256Pfizer[S,S]-reboxetine

Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia

Start: Oct 2007Est. completion: May 2009500 patients
Phase 3Terminated
NCT00346034PfizerPregabalin

This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

Start: Dec 2006Est. completion: Feb 2008357 patients
Phase 3Completed
NCT00423605Jazz PharmaceuticalsXyrem®

Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

Start: Dec 2006Est. completion: Jan 2010560 patients
Phase 3Completed
NCT00371137Jazz PharmaceuticalsXyrem®

A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia

Start: Aug 2006Est. completion: Dec 2008548 patients
Phase 3Completed
NCT00333866Pfizerpregabalin

Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.

Start: Jul 2006Est. completion: Nov 2007747 patients
Phase 3Completed
NCT00230776Pfizerpregabalin

A Controlled Pregabalin Trial In Fibromyalgia

Start: Oct 2005Est. completion: Jul 2006740 patients
Phase 3Completed
NCT00233025Prevail TherapeuticsDuloxetine

Duloxetine Versus Placebo in the Treatment of FMS

Start: Sep 2005Est. completion: Jun 2007320 patients
Phase 3Completed
NCT00125892Prevail Therapeuticsduloxetine

A Study of Duloxetine in the Treatment of Fibromyalgia

Start: Jul 2005Est. completion: Mar 2007320 patients
Phase 3Completed
NCT00190866Prevail TherapeuticsDuloxetine

Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

Start: Jun 2005Est. completion: Jun 2007210 patients
Phase 3Completed
NCT00151489Pfizerpregabalin

Safety and Efficacy Study of Pregabalin in Fibromyalgia

Start: Apr 2005Est. completion: Jun 20061,020 patients
Phase 3Completed
NCT00151528PfizerPregabalin

An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

Start: Jan 2005Est. completion: Jun 2006428 patients
Phase 3Completed
NCT00645398PfizerPregabalin

A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia

Start: Sep 2004Est. completion: Jun 2005751 patients
Phase 3Completed
NCT01107574Oregon TherapeuticsGabapentin

Fibromyalgia Treatment Trial With Gabapentin and Osteopathic Manipulative Medicine

Start: Apr 2004Est. completion: Apr 201041 patients
Phase 3Completed
NCT00489073Prevail Therapeuticsduloxetine

Duloxetine Versus Placebo for Fibromyalgia

Start: Nov 2002Est. completion: Dec 2003345 patients
Phase 3Completed
NCT00301431PfizerDVS-233

Study Evaluating the Efficacy of DVS-233 in Fibromyalgia

Start: Aug 2006Est. completion: Jun 20071,050 patients
Phase 2/3Terminated
NCT06752590Ono PharmaceuticalONO-1110

A Clinical Study of ONO-1110 in Patients With Fibromyalgia

Start: Mar 2025Est. completion: Sep 2026160 patients
Phase 2Active Not Recruiting
NCT05643794UCB Pharmarozanolixizumab

A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome

Start: Dec 2022Est. completion: Jul 202463 patients
Phase 2Completed
NCT03965091TevaFremanezumab

A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia

Start: Jul 2019Est. completion: Jan 2022189 patients
Phase 2Terminated
NCT03092726AstellasASP8062

A Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia

Start: May 2017Est. completion: Mar 2018183 patients
Phase 2Completed
NCT03056690AstellasASP0819

A Study to Assess the Analgesic Efficacy and Safety of ASP0819 in Patients With Fibromyalgia

Start: Mar 2017Est. completion: Feb 2018186 patients
Phase 2Completed
NCT01693692Theravance BiopharmaTD-9855 Group 1

Phase 2 Study of TD-9855 to Treat Fibromyalgia

Start: Nov 2012Est. completion: Apr 2014392 patients
Phase 2Completed
NCT01287481Providence TherapeuticsStress and Emotions

Pain and Stress Management for Fibromyalgia

Start: May 2011Est. completion: Jul 2015230 patients
Phase 2Completed
NCT00752505PfizerEsreboxetine

A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia.

Start: Aug 2008Est. completion: Jun 200989 patients
Phase 2Completed
NCT00689052Boehringer Ingelheimpramipexole ER

Pramipexole ER vs. Placebo in Fibromyalgia

Start: Jul 200861 patients
Phase 2Terminated
NCT00176163Heidelberg PharmaOperant behavioral treatment; Drug: THC

Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain

Start: Aug 2005Est. completion: May 2009240 patients
Phase 2Completed
NCT00116129MSDIbutamoren Mesylate

Efficacy and Safety of an Oral Growth Hormone Drug in the Treatment of Fibromyalgia

Start: Jul 2005Est. completion: Apr 200864 patients
Phase 2Completed

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

26 late-stage (Phase 3) programs, potential near-term approvals
30 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.