Skip to main content

Fibromyalgia

61
Pipeline Programs
30
Companies
50
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
6
1
7
1
38
8
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
2100%
+ 112 programs with unclassified modality

On Market (2)

Approved therapies currently available

Viatris
LYRICA CRApproved
pregabalin
Viatris
oral2017
402K Part D
Eli Lilly and Company
CYMBALTAApproved
duloxetine hydrochloride
Eli Lilly and Company
oral2004

Competitive Landscape

43 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 4
EsreboxetinePhase 32 trials
PregabalinPhase 3
+18 more programs
Active Trials
NCT00819624Completed185Est. Mar 2009
NCT01203865Unknown1,200Est. Mar 2012
NCT00809289Completed40Est. Jul 2009
+8 more trials
Viatris
ViatrisCANONSBURG, PA
15 programs
1
12
1
pregabalinPhase 41 trial
PregabalinPhase 31 trial
PregabalinPhase 31 trial
PregabalinPhase 31 trial
PregabalinPhase 31 trial
+10 more programs
Active Trials
NCT01280747Terminated42Est. Apr 2012
NCT00760474Completed27Est. Mar 2011
NCT00883740Completed119Est. Jun 2010
+12 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
NCT01621191Completed149Est. Feb 2014
NCT00233025Completed320Est. Jun 2007
+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
Sharp Therapeutics
1 program
1
Ibutamoren MesylatePhase 21 trial
Active Trials
NCT00116129Completed64Est. Apr 2008
MSD
MSDIreland - Ballydine
1 program
1
Ibutamoren MesylatePhase 2
Ono Pharmaceutical
1 program
1
ONO-1110Phase 21 trial
Active Trials
NCT06752590Completed175Est. May 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
NCT00423605Completed560Est. Jan 2010
+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
NCT05907538Unknown84Est. Jun 2024
NCT05907590Unknown52Est. Dec 2023
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
UCB PharmaBelgium - Brussels
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

+13 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Verona Pharmamicronized and ultra-micronized Palmitoylethanolamide
PfizerPregabalin
Viatrispregabalin
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: 16,283 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
NCT01020526Viatrispregabalin

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
NCT01387607Viatrispregabalin

A Study For Pregabalin In Patients With Fibromyalgia

Start: Feb 2012Est. completion: Oct 2016343 patients
Phase 3Completed
NCT01432236ViatrisPregabalin

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

Start: Oct 2011Est. completion: Jul 2013197 patients
Phase 3Completed
NCT01271933Viatrispregabalin

Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients

Start: Mar 2011Est. completion: Jul 2012441 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
NCT00830128Viatrispregabalin

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

Start: Jul 2009Est. completion: Feb 2011106 patients
Phase 3Completed
NCT00883740ViatrisPregabalin

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
NCT00423605Jazz PharmaceuticalsXyrem®

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

Start: Dec 2006Est. completion: Jan 2010560 patients
Phase 3Completed
NCT00346034ViatrisPregabalin

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

Start: Dec 2006Est. completion: Feb 2008357 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
NCT00333866Viatrispregabalin

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

Start: Jul 2006Est. completion: Nov 2007747 patients
Phase 3Completed
NCT00282997Viatrispregabalin

A Safety Study Of Pregabalin In Fibromyalgia

Start: Feb 2006Est. completion: Oct 2006500 patients
Phase 3Completed
NCT00230776Viatrispregabalin

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
NCT00151489Viatrispregabalin

Safety and Efficacy Study of Pregabalin in Fibromyalgia

Start: Apr 2005Est. completion: Jun 20061,020 patients
Phase 3Completed
NCT00151528ViatrisPregabalin

An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

Start: Jan 2005Est. completion: Jun 2006428 patients
Phase 3Completed
NCT00645398ViatrisPregabalin

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: May 2026175 patients
Phase 2Completed
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

Related Jobs

Senior Internal Auditor - SOX Compliance

Tonix PharmaceuticalsTonix Pharmaceuticals
Berkeley Heights, NJ
5d ago
$80K - $110K/yr

Executive Assistant to the Chief Executive Officer

Tonix PharmaceuticalsTonix Pharmaceuticals
Berkeley Heights, NJ or New York, NY
1w ago
$100K - $160K/yr

Associate Medical Director, Clinical Development

Tonix PharmaceuticalsTonix Pharmaceuticals
Berkeley Heights, NJ
3w ago
$180K - $240K/yr

Manager, SEC Reporting

Tonix PharmaceuticalsTonix Pharmaceuticals
Berkeley Heights, NJ
3w ago
$100K - $150K/yr

Senior Associate, Supplier Quality

Tonix PharmaceuticalsTonix Pharmaceuticals
North Dartmouth, MA or Berkeley Height, NJ
3w ago
$80K - $110K/yr

Senior Manager, Information Security

Tonix PharmaceuticalsTonix Pharmaceuticals
Frederick, MD
1mo ago
$130K - $170K/yr

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

38 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.