TherapeuticsMD, Inc.
TXMDDrugs in Pipeline
306
Phase 3 Programs
108
Upcoming Catalysts
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NPT 2042 Phase 2 Est. Readout
Estimated primary completion for NPT 2042 trial (NCT06769659) in Epilepsy, Generalized. Topline data typically follows completion by weeks to months.
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How TXMD's past catalysts played out
Factor VIII (rFVIIIFc)
Severe Hemophilia A
enclomiphene citrate
Effect of Treatment on Bone Mineral Density
REL-1017
Major Depressive Disorder
Dexycu
Inflammation
ETC-1002
Hypercholesterolemia
Human platelets
Cardiac Surgery
Pegtibatinase
Homocystinuria
3.2 mg intranasal carbetocin
Prader-Willi Syndrome
XIAFLEX / XIAPEX
Dupuytren's Contracture
Prednisolone Acetate
Uveitis
Brepocitinib PO QD
Uveitis, Posterior
JP-1366 20mg
Erosive Esophagitis
Neridronate
Complex Regional Pain Syndrome Type I
BFF MDI 320/9.6 μg
Chronic Obstructive Pulmonary Disorder
YL201
Advanced Esophageal Squamous Cell Carcinoma
BHV-1300
Graves Disease
Botulinum Toxins, Type A
Glabellar Frown Lines
Triamcinolone Hexacetonide
Knee Osteoarthritis
Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler
COPD
Meropenem-Vaborbactam
Urinary Tract Infection Complicated
Oral Brepocitinib
Cutaneous Sarcoidosis
cyclosporine
Dry Eye Syndromes
Saroglitazar Magnesium 2 mg
Primary Biliary Cholangitis
BGF MDI 320/14.4/9.6 μg
COPD
Single-Dose IV Oritavancin Diphosphate
Wound Infection
Oxymorphone Extended Release
Chronic Pain
Frovatriptan 2.5mg QD
Migraine
Reproxalap Ophthalmic Solution (0.25%)
Dry Eye
Frovatriptan 2.5 mg
Migraine
BGF MDI (PT010)
COPD
delafloxacin
Skin and Subcutaneous Tissue Bacterial Infections
Saroglitazar magnesium 1 mg
Non-Alcoholic Fatty Liver Disease
Pimicotinib(ABSK021)
Tenosynovial Giant Cell Tumor
GFF MDI (PT003) 14.4/9.6 μg
COPD
arbaclofen
Fragile X Syndrome
Frovatriptan
Menstrually Associated Migraine
CR845
Uremic Pruritus
Oral Calcitonin Tablets
Osteoporosis, Postmenopausal
EN3835
Adhesive Capsulitis
pagoclone
Stuttering
GFF MDI (PT003)
COPD
Eribulin
Locally Advanced or Metastatic Breast Cancer
ACER-002 (celiprolol) 200 mg BID
Vascular Ehlers-Danlos Syndrome
Difluprednate Ophthalmic Emulsion
Inflammation
AR101
Peanut Allergy
Androxal 12.5 mg or 25 mg
Secondary Hypogonadism
Collagenase clostridium histolyticum
Dupuytren's Disease
FMX101
Acne Vulgaris
Scopolamine
Motion Sickness
YL202
Non-Small Cell Lung Cancer
GS1191-0445 injection
Hemophilia A
AXS-05
Agitation in Patients With Dementia of the Alzheimer's Type
Plozasiran
Familial Chylomicronemia Syndrome
BHV-7000
Focal Epilepsy
Fasedienol Nasal Spray
Social Anxiety Disorder
bempedoic acid
Hypercholesterolemia
Veverimer
CKD
DPI-386 Nasal Gel
Motion Sickness, Space
BFF MDI (PT009) 320/9.6 μg
Chronic Obstructive Pulmonary Disorder
FMX103 minocycline foam 1.5%
Facial Papulopustular Rosacea
Ublituximab
Relapsing Remitting Multiple Sclerosis
000-0551 Lotion
Plaque Psoriasis
Topical SM04554 solution
Androgenetic Alopecia
RBT-1
Post-Operative Complications in Cardiac Surgery
AR101 powder provided in capsules & sachets
Peanut Allergy
A-101 Solution
Seborrheic Keratosis
Moxifloxacin
Community Acquired Bacterial Pneumonia
XAF5 (concentration A: 0.1%)
Steatoblepharon
PTX-022
Pachyonychia Congenita
Radiprodil
GRIN-related Neurodevelopmental Disorder
Solriamfetol 300 mg
Major Depressive Disorder
Androxal
Secondary Hypogonadism
ADX-102 Ophthalmic Solution (0.5%)
Non-infectious Anterior Uveitis
Linsitinib
Thyroid Eye Disease
AXS-07 (MoSEIC meloxicam and rizatriptan)
Migraine
PRO 2000/5
HIV Infections
ELA026
Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
DaxibotulinumtoxinA for injection
Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)
GP MDI (PT001) 14.4 μg
COPD, Chronic Obstructive Pulmonary Disease
histrelin acetate
Prostate Cancer
AC-170 0.24%
Allergic Conjunctivitis
Scopolamine Nasal Gel
Motion Sickness
AXS-05 (dextromethorphan-bupropion)
Agitation in Patients With Dementia of the Alzheimer's Type
Estradiol
Menopause
KarXT
Psychosis Associated With Alzheimer's Disease
Triamcinolone Acetonide
Osteoarthritis of the Knee
Progesterone
Menopause
Xanomeline and Trospium Chloride Capsules
Schizophrenia
AA4500
Peyronie's Disease
Lorecivivint
Knee Osteoarthritis
Zelpultide alfa
Bronchopulmonary Dysplasia
oxymorphone HCl
Post Operative Pain
anamorelin HCl
Carcinoma, Non-Small-Cell Lung
GP MDI (PT001)
Chronic Obstructive Pulmonary Disease (COPD)
Dalbavancin
Abscess
Valrubicin, 800 mg
Carcinoma in Situ
Androxal 12.5 mg/25 mg
Secondary Hypogonadism
Nirogacestat oral tablet
Desmoid Tumor
MST-188
Vaso-occlusive Crisis
Loncastuximab Tesirine
Relapsed Diffuse Large B-Cell Lymphoma
Testosterone
Hypogonadism
Nefecon
Primary IgA Nephropathy
Teriflunomide
Relapsing Multiple Sclerosis (RMS)
Tiratricol
Monocarboxylate Transporter 8 Deficiency
Leriglitazone
Cerebral Adrenoleukodystrophy (cALD)
Oxymorphone immediate release
Acute Pain
Difluprednate
Inflammation
JDP-205 Injection
Acute Urticaria
RT001
Lateral Canthal Lines
Trivalent ganglioside vaccine
Sarcoma
PT005 MDI
Chronic Obstructive Pulmonary Disease
AVZO-021
Advanced Solid Tumor
ABSK-011+BSC
Hepatocellular Carcinoma (HCC)
PTI-808
Healthy Volunteer - Complete
Oral testosterone undecanoate (containing 300 mg T)
Male Hypogonadism
NVG-2089
Immune Thrombocytopenia (ITP)
TD-6450
Hepatitis C Viral Infection
VAL-083, Dianhydrogalactitol
Glioma
Mocetinostat
Urothelial Carcinoma
NPT 2042
Epilepsy, Generalized
YL202 should be intravenously infused
NSCLC
NFX-179 gel
Cutaneous Neurofibroma
LM103 TILs Injection
Non-Small Cell Lung Cancer
PT001 MDI
Chronic Obstructive Pulmonary Disease
YL242
Advanced Solid Tumor
NDV-3A
Vulvovaginal Candidiasis
Saroglitazar Magnesium 2mg
Non Alcoholic Steatohepatitis
MGCD0103
Lymphoma
dotinurad
Gout
TH9619
Solid Tumor
Orvepitant Maleate
Chronic Refractory Cough
botulinum toxin, Type A
Lateral Canthal Lines
CQSS2
Smoking Cessation
ABT-101
Advanced Solid Tumor
ETX-19477
Advanced or Metastatic Solid Tumors
FT-2102
Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme)
Latanoprost-PPDS
Glaucoma
RNK08954-01
KRAS G12D Mutation
2B3-101
Brain Metastases
TG-0054
Multiple Myeloma
FT-2102 (olutasidenib)
Acute Myeloid Leukemia
CTS3497
Solid Tumor
Gene Therapy-vMCO-010
Stargardt Disease
ST-01
Chronic Pain
A-101
Seborrheic Keratosis
Naproxen sodium
Gastric Ulcer
LY2940094
Alcoholism
Cenicriviroc 100 mg
HIV-1 Infection
Telapristone Acetate
Uterine Fibroids
lisocabtagene maraleucel
Lymphoma, Non-Hodgkin
BFF MDI 160/9.6 μg
Chronic Obstructive Pulmonary Disease
Saroglitazar Magnesium 4 mg
Nonalcoholic Steatohepatitis
BIO-106
Advanced Cancer
Latanoprost Punctal Plug Delivery System
Ocular Hypertension
TNP-2092 for injection
Periprosthetic Joint Infection (PJI)
Lidoderm
Osteoarthritis, Knee
Glycopyrronium MDI
Asthma
MAA868 Cohort 1
Atrial Fibrillation
AVZO-103
Solid Tumor Cancer
DAXI for injection 250 U
Upper Limb Spasticity
NMRA-335140
Major Depressive Disorder
Nexagon® Low Dose
Venous Leg Ulcers
JP-1366
GERD
T0903131 Besylate
Diabetes Mellitus, Type II
hPSC-CM Therapy
Heart Failure
SLS-002
Depressive Disorder, Major
AVZO-1418
Solid Tumor Cancer
Botulinum Toxin Type A
Glabellar Frown Lines
Aglatimagene besadenovec
Borderline Resectable Pancreatic Adenocarcinoma
EL219
Invasive Mould Infection
Setanaxib
Alport Syndrome
H-1337 0.6%
Glaucoma Open-Angle Primary
EFB0027 (metformin delayed release)
Type 2 Diabetes Mellitus
50 mg Usnoflast
Amyotrophic Lateral Sclerosis (ALS)
AMT-116
Advanced Solid Tumors
hI-con1
Choroidal Neovascularization
BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)
Colorectal Cancer
Rhu-pGSN
Acute Respiratory Distress Syndrome
MIN-102
Friedreich Ataxia
AC-150 Combo
Allergic Conjunctivitis
ET140203 T Cells
Hepatoblastoma
TNP-2092 capsules
Hyperammonemia
Camidanlumab Tesirine
Relapsed Hodgkin Lymphoma
Met DR
Type 2 Diabetes Mellitus
INT131 besylate
Type 2 Diabetes Mellitus
FP01
Acute Cough
TST001
Advanced Cancer
pegylated IFNa2b
Hepatitis C
Linezolid
Skin and Subcutaneous Tissue Bacterial Infections
Tranilast
Gout
BC-819/PEI
Superficial Bladder Cancer
Faldaprevir
Hepatitis C Viral Infection
GKT137831
Type 2 Diabetes Mellitus With Diabetic Nephropathy
ABT-301
Colorectal Cancer (Diagnosis)
VB10.16
HPV Positive Oropharyngeal Squamous Cell Carcinoma
AdVEGFXC1
Coronary Artery Disease
ST-100 Ophthalmic Solution
Dry Eye Disease
RT001 (Botulinum Toxin Type A Topical Gel)
Lateral Canthal Lines
JTX-8064
Cancer
ATI-450
Hidradenitis Suppurativa
PTG-300
Polycythemia Vera
Active
Asthma
PRTX007
Melanoma Stage III
NAP (Naptumomab estafenatox)
Non-small Cell Lung Cancer
Ipamorelin
Gastrointestinal Dysmotility
MSDC-0602K
Non-alcoholic Fatty Liver Disease
25 mg Androxal
Secondary Hypogonadism
Testosterone undecanoate
Hypogonadism
Allo-QuadCAR01-T
Lymphoma Diffuse Large B-cell
188-0551 Solution
Plaque Psoriasis
IG3018
Hyperuricemia
YL201 for Injection
Advanced Solid Tumor
5 mg Serlopitant Tablets
Pruritus
VLS-1488
Advanced Solid Tumor
Halobetasol Propionate Lotion 0.05%
Psoriasis
octreotide acetate
Acromegaly
OPN-305
Myelodysplastic Syndrome
Gene Therapy product:vMCO-I
Retinitis Pigmentosa
GFH018
NSCLC, Stage III
Sevuparin
Sickle-Cell Disease
voretigene neparvovec-rzyl
Leber Congenital Amaurosis
AXS-12 (Reboxetine)
Narcolepsy
CB-03-01
Acne Vulgaris
SRP1020
Advanced Solid Tumors
Gene Therapy Product-MCO-010
Retinitis Pigmentosa
Arm 1: SOC (mTOR + CNI)
Kidney Transplantation
Oral Testosterone Undecanoate
Hypogonadism
VK2735
Weight Loss
Latanoprost
Open-Angle Glaucoma
UHE-105
Scalp Psoriasis
Recombinant Human Plasma Gelsolin
Community-acquired Pneumonia
NT100
Repeated IVF Failure
XOPH5 Ointment
Lower Eyelid Steatoblepharon (Excess Eyelid Fat)
ECT204 T cells
Hepatocellular Carcinoma
fludarabine phosphate
Accelerated Phase Chronic Myelogenous Leukemia
ABSK043 in combination with Glecirasib
Non-Small Cell Lung Cancer
RIST4721
Palmoplantar Pustulosis
PT-112
Non-Small Cell Lung Cancer (NSCLC)
TG-0054 combined with G-CSF
Multiple Myeloma
PTX-200
Acute Leukemia
ABSK043 in combination with Firmonertinib
Non-Small Cell Lung Cancer With EGFR Mutation
trospium chloride inhalation powder (TrIP)
Chronic Obstructive Pulmonary Disease
Oral rsCT tablet
Phase 1 Pharmacodynamic Study
RNK05047
Advanced Solid Tumor
12.5 mg Proellex
Uterine Fibroids
SRSD107
Coronary Artery Disease (CAD)
SL-701; poly-ICLC (polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose)
Adult Brain Glioblastoma
Brepocitinib
Dermatomyositis
RAP-219
Focal Epilepsy
PER-001 Intravitreal Implant - Low Dose
Diabetic Retinopathy
RNK08954
KRAS G12D Mutations
DAXI 80 U
Plantar Fasciitis
DAXXIFY
Glabellar Frown Lines
Norketotifen
Allergic Rhinitis
LT3001 Drug Product
Acute Ischemic Stroke
ABX-002
Major Depressive Disorder
ETX-018810
Diabetic Peripheral Neuropathic Pain
ALT-100 mAb
Acute Respiratory Distress Syndrome (ARDS)
CT-868
Obesity
JCARH125
Multiple Myeloma
pTTL
Colorectal Cancer
AFNT-211
Pancreatic Ductal Adenocarcinoma
RT001 Botulinum toxin type A (Dose A)
Lateral Canthal Lines
SM04554
Androgenetic Alopecia
AHB-137
Hepatitis B, Chronic
ANG003 Dose A
Exocrine Pancreatic Insufficiency (EPI)
AT-007
Classic Galactosemia
SF0166 Topical Ophthalmic Solution
Age-Related Macular Degeneration
Eteplirsen
Muscular Dystrophy, Duchenne
Etavopivat
Sickle Cell Disease
ADX-629
Chronic Cough
BTRX-246040
Parkinson Disease
IMC-001
Extranodal NK/T-cell Lymphoma, Nasal Type
RM-131
Constipation
Enicepatide
Obesity
TT-034
Hepatitis C
ARD-101
Bariatric Surgery
CCH-aaes
Edematous Fibrosclerotic Panniculopathy
SM04690
Osteoarthritis
Triac
Allan-Herndon-Dudley Syndrome
TG-0054 (2.24 mg/kg)
Multiple Myeloma
VSA006
Nash
CTI-1601
Friedreich Ataxia
Inhaled PT001
Chronic Obstructive Pulmonary Disease
EHT102 Injection
Treatment of Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
HG004
Leber Congenital Amaurosis
ABSK061 + ABSK043
HER2-Gastric/Gastroesophageal Junction Cancer
Radezolid
Community-Acquired Pneumonia (CAP)
Tagraxofusp
Acute Myeloid Leukemia
QTORIN 3.9% rapamycin anhydrous gel
Cutaneous Venous Malformations
Bemarituzumab
Gastric Cancer
RZL-012+Lidacaine injection prior treatment
Submental Fat
ACER-801 50 mg BID
Post-menopausal Vasomotor Symptoms
AZD2115 Dose 1
Chronic Obstructive Pulmonary Disease (COPD)
INT-210 Capsule
Ulcerative Colitis (UC)
SKP-1041 (experimental formulation of zaleplon)
Sleep Disorder
CT3001
Solid Tumor, Adult
CT041
Gastric Cancer
Saroglitazar
Liver Transplant; Complications
Bone marrow mesenchymal stem cells
Osteoarthritis, Knee
JPI-547
Pancreatic Ductal Adenocarcinoma
Solabegron immediate release tablets, low dose
Overactive Bladder
Varenicline tartrate
Trigeminal Neuralgia
15mg T3D-959
Alzheimer Disease
RZL-012
Submental Fat
Solabegron modified release tablets, low dose
Overactive Bladder
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
Factor VIII (rFVIIIFc) | Phase 3 | Severe Hemophilia A | - | - |
enclomiphene citrate | Phase 3 | Effect of Treatment on Bone Mineral Density | - | - |
REL-1017 | Phase 3 | Major Depressive Disorder | - | - |
Dexycu | Phase 3 | Inflammation | - | - |
ETC-1002 | Phase 3 | Hypercholesterolemia | - | - |
Human platelets | Phase 3 | Cardiac Surgery | - | - |
Pegtibatinase | Phase 3 | Homocystinuria | - | - |
3.2 mg intranasal carbetocin | Phase 3 | Prader-Willi Syndrome | - | - |
XIAFLEX / XIAPEX | Phase 3 | Dupuytren's Contracture | - | - |
Prednisolone Acetate | Phase 3 | Uveitis | - | - |
Brepocitinib PO QD | Phase 3 | Uveitis, Posterior | - | - |
JP-1366 20mg | Phase 3 | Erosive Esophagitis | - | - |
Neridronate | Phase 3 | Complex Regional Pain Syndrome Type I | - | - |
BFF MDI 320/9.6 μg | Phase 3 | Chronic Obstructive Pulmonary Disorder | - | - |
YL201 | Phase 3 | Advanced Esophageal Squamous Cell Carcinoma | - | - |
BHV-1300 | Phase 3 | Graves Disease | - | - |
Botulinum Toxins, Type A | Phase 3 | Glabellar Frown Lines | - | - |
Triamcinolone Hexacetonide | Phase 3 | Knee Osteoarthritis | - | - |
Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler | Phase 3 | COPD | - | - |
Meropenem-Vaborbactam | Phase 3 | Urinary Tract Infection Complicated | - | - |
Oral Brepocitinib | Phase 3 | Cutaneous Sarcoidosis | - | - |
cyclosporine | Phase 3 | Dry Eye Syndromes | - | - |
Saroglitazar Magnesium 2 mg | Phase 3 | Primary Biliary Cholangitis | - | - |
BGF MDI 320/14.4/9.6 μg | Phase 3 | COPD | - | - |
Single-Dose IV Oritavancin Diphosphate | Phase 3 | Wound Infection | - | - |
Oxymorphone Extended Release | Phase 3 | Chronic Pain | - | - |
Frovatriptan 2.5mg QD | Phase 3 | Migraine | - | - |
Reproxalap Ophthalmic Solution (0.25%) | Phase 3 | Dry Eye | - | - |
Frovatriptan 2.5 mg | Phase 3 | Migraine | - | - |
BGF MDI (PT010) | Phase 3 | COPD | - | - |
delafloxacin | Phase 3 | Skin and Subcutaneous Tissue Bacterial Infections | - | - |
Saroglitazar magnesium 1 mg | Phase 3 | Non-Alcoholic Fatty Liver Disease | - | - |
Pimicotinib(ABSK021) | Phase 3 | Tenosynovial Giant Cell Tumor | - | - |
GFF MDI (PT003) 14.4/9.6 μg | Phase 3 | COPD | - | - |
arbaclofen | Phase 3 | Fragile X Syndrome | - | - |
Frovatriptan | Phase 3 | Menstrually Associated Migraine | - | - |
CR845 | Phase 3 | Uremic Pruritus | - | - |
Oral Calcitonin Tablets | Phase 3 | Osteoporosis, Postmenopausal | - | - |
EN3835 | Phase 3 | Adhesive Capsulitis | - | - |
pagoclone | Phase 3 | Stuttering | - | - |
GFF MDI (PT003) | Phase 3 | COPD | - | - |
Eribulin | Phase 3 | Locally Advanced or Metastatic Breast Cancer | - | - |
ACER-002 (celiprolol) 200 mg BID | Phase 3 | Vascular Ehlers-Danlos Syndrome | - | - |
Difluprednate Ophthalmic Emulsion | Phase 3 | Inflammation | - | - |
AR101 | Phase 3 | Peanut Allergy | - | - |
Androxal 12.5 mg or 25 mg | Phase 3 | Secondary Hypogonadism | - | - |
Collagenase clostridium histolyticum | Phase 3 | Dupuytren's Disease | - | - |
FMX101 | Phase 3 | Acne Vulgaris | - | - |
Scopolamine | Phase 3 | Motion Sickness | - | - |
YL202 | Phase 3 | Non-Small Cell Lung Cancer | - | - |
GS1191-0445 injection | Phase 3 | Hemophilia A | - | - |
AXS-05 | Phase 3 | Agitation in Patients With Dementia of the Alzheimer's Type | - | - |
Plozasiran | Phase 3 | Familial Chylomicronemia Syndrome | - | - |
BHV-7000 | Phase 3 | Focal Epilepsy | - | - |
Fasedienol Nasal Spray | Phase 3 | Social Anxiety Disorder | - | - |
bempedoic acid | Phase 3 | Hypercholesterolemia | - | - |
Veverimer | Phase 3 | CKD | - | - |
DPI-386 Nasal Gel | Phase 3 | Motion Sickness, Space | - | - |
BFF MDI (PT009) 320/9.6 μg | Phase 3 | Chronic Obstructive Pulmonary Disorder | - | - |
FMX103 minocycline foam 1.5% | Phase 3 | Facial Papulopustular Rosacea | - | - |
Ublituximab | Phase 3 | Relapsing Remitting Multiple Sclerosis | - | - |
000-0551 Lotion | Phase 3 | Plaque Psoriasis | - | - |
Topical SM04554 solution | Phase 3 | Androgenetic Alopecia | - | - |
RBT-1 | Phase 3 | Post-Operative Complications in Cardiac Surgery | - | - |
AR101 powder provided in capsules & sachets | Phase 3 | Peanut Allergy | - | - |
A-101 Solution | Phase 3 | Seborrheic Keratosis | - | - |
Moxifloxacin | Phase 3 | Community Acquired Bacterial Pneumonia | - | - |
XAF5 (concentration A: 0.1%) | Phase 3 | Steatoblepharon | - | - |
PTX-022 | Phase 3 | Pachyonychia Congenita | - | - |
Radiprodil | Phase 3 | GRIN-related Neurodevelopmental Disorder | - | - |
Solriamfetol 300 mg | Phase 3 | Major Depressive Disorder | - | - |
Androxal | Phase 3 | Secondary Hypogonadism | - | - |
ADX-102 Ophthalmic Solution (0.5%) | Phase 3 | Non-infectious Anterior Uveitis | - | - |
Linsitinib | Phase 3 | Thyroid Eye Disease | - | - |
AXS-07 (MoSEIC meloxicam and rizatriptan) | Phase 3 | Migraine | - | - |
PRO 2000/5 | Phase 3 | HIV Infections | - | - |
ELA026 | Phase 3 | Secondary Hemophagocytic Lymphohistiocytosis (sHLH) | - | - |
DaxibotulinumtoxinA for injection | Phase 3 | Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines) | - | - |
GP MDI (PT001) 14.4 μg | Phase 3 | COPD, Chronic Obstructive Pulmonary Disease | - | - |
histrelin acetate | Phase 3 | Prostate Cancer | - | - |
AC-170 0.24% | Phase 3 | Allergic Conjunctivitis | - | - |
Scopolamine Nasal Gel | Phase 3 | Motion Sickness | - | - |
AXS-05 (dextromethorphan-bupropion) | Phase 3 | Agitation in Patients With Dementia of the Alzheimer's Type | - | - |
Estradiol | Phase 3 | Menopause | - | - |
KarXT | Phase 3 | Psychosis Associated With Alzheimer's Disease | - | - |
Triamcinolone Acetonide | Phase 3 | Osteoarthritis of the Knee | - | - |
Progesterone | Phase 3 | Menopause | - | - |
Xanomeline and Trospium Chloride Capsules | Phase 3 | Schizophrenia | - | - |
AA4500 | Phase 3 | Peyronie's Disease | - | - |
Lorecivivint | Phase 3 | Knee Osteoarthritis | - | - |
Zelpultide alfa | Phase 3 | Bronchopulmonary Dysplasia | - | - |
oxymorphone HCl | Phase 3 | Post Operative Pain | - | - |
anamorelin HCl | Phase 3 | Carcinoma, Non-Small-Cell Lung | - | - |
GP MDI (PT001) | Phase 3 | Chronic Obstructive Pulmonary Disease (COPD) | - | - |
Dalbavancin | Phase 3 | Abscess | - | - |
Valrubicin, 800 mg | Phase 3 | Carcinoma in Situ | - | - |
Androxal 12.5 mg/25 mg | Phase 3 | Secondary Hypogonadism | - | - |
Nirogacestat oral tablet | Phase 3 | Desmoid Tumor | - | - |
MST-188 | Phase 3 | Vaso-occlusive Crisis | - | - |
Loncastuximab Tesirine | Phase 3 | Relapsed Diffuse Large B-Cell Lymphoma | - | - |
Testosterone | Phase 3 | Hypogonadism | - | - |
Nefecon | Phase 3 | Primary IgA Nephropathy | - | - |
Teriflunomide | Phase 3 | Relapsing Multiple Sclerosis (RMS) | - | - |
Tiratricol | Phase 3 | Monocarboxylate Transporter 8 Deficiency | - | - |
Leriglitazone | Phase 3 | Cerebral Adrenoleukodystrophy (cALD) | - | - |
Oxymorphone immediate release | Phase 3 | Acute Pain | - | - |
Difluprednate | Phase 3 | Inflammation | - | - |
JDP-205 Injection | Phase 3 | Acute Urticaria | - | - |
RT001 | Phase 2 | Lateral Canthal Lines | - | - |
Trivalent ganglioside vaccine | Phase 2 | Sarcoma | - | - |
PT005 MDI | Phase 2 | Chronic Obstructive Pulmonary Disease | - | - |
AVZO-021 | Phase 2 | Advanced Solid Tumor | - | - |
ABSK-011+BSC | Phase 2 | Hepatocellular Carcinoma (HCC) | - | - |
PTI-808 | Phase 2 | Healthy Volunteer - Complete | - | - |
Oral testosterone undecanoate (containing 300 mg T) | Phase 2 | Male Hypogonadism | - | - |
NVG-2089 | Phase 2 | Immune Thrombocytopenia (ITP) | - | - |
TD-6450 | Phase 2 | Hepatitis C Viral Infection | - | - |
VAL-083, Dianhydrogalactitol | Phase 2 | Glioma | - | - |
Mocetinostat | Phase 2 | Urothelial Carcinoma | - | - |
NPT 2042 | Phase 2 | Epilepsy, Generalized | - | - |
YL202 should be intravenously infused | Phase 2 | NSCLC | - | - |
NFX-179 gel | Phase 2 | Cutaneous Neurofibroma | - | - |
LM103 TILs Injection | Phase 2 | Non-Small Cell Lung Cancer | - | - |
PT001 MDI | Phase 2 | Chronic Obstructive Pulmonary Disease | - | - |
YL242 | Phase 2 | Advanced Solid Tumor | - | - |
NDV-3A | Phase 2 | Vulvovaginal Candidiasis | - | - |
Saroglitazar Magnesium 2mg | Phase 2 | Non Alcoholic Steatohepatitis | - | - |
MGCD0103 | Phase 2 | Lymphoma | - | - |
dotinurad | Phase 2 | Gout | - | - |
TH9619 | Phase 2 | Solid Tumor | - | - |
Orvepitant Maleate | Phase 2 | Chronic Refractory Cough | - | - |
botulinum toxin, Type A | Phase 2 | Lateral Canthal Lines | - | - |
CQSS2 | Phase 2 | Smoking Cessation | - | - |
ABT-101 | Phase 2 | Advanced Solid Tumor | - | - |
ETX-19477 | Phase 2 | Advanced or Metastatic Solid Tumors | - | - |
FT-2102 | Phase 2 | Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme) | - | - |
Latanoprost-PPDS | Phase 2 | Glaucoma | - | - |
RNK08954-01 | Phase 2 | KRAS G12D Mutation | - | - |
2B3-101 | Phase 2 | Brain Metastases | - | - |
TG-0054 | Phase 2 | Multiple Myeloma | - | - |
FT-2102 (olutasidenib) | Phase 2 | Acute Myeloid Leukemia | - | - |
CTS3497 | Phase 2 | Solid Tumor | - | - |
Gene Therapy-vMCO-010 | Phase 2 | Stargardt Disease | - | - |
ST-01 | Phase 2 | Chronic Pain | - | - |
A-101 | Phase 2 | Seborrheic Keratosis | - | - |
Naproxen sodium | Phase 2 | Gastric Ulcer | - | - |
LY2940094 | Phase 2 | Alcoholism | - | - |
Cenicriviroc 100 mg | Phase 2 | HIV-1 Infection | - | - |
Telapristone Acetate | Phase 2 | Uterine Fibroids | - | - |
lisocabtagene maraleucel | Phase 2 | Lymphoma, Non-Hodgkin | - | - |
BFF MDI 160/9.6 μg | Phase 2 | Chronic Obstructive Pulmonary Disease | - | - |
Saroglitazar Magnesium 4 mg | Phase 2 | Nonalcoholic Steatohepatitis | - | - |
BIO-106 | Phase 2 | Advanced Cancer | - | - |
Latanoprost Punctal Plug Delivery System | Phase 2 | Ocular Hypertension | - | - |
TNP-2092 for injection | Phase 2 | Periprosthetic Joint Infection (PJI) | - | - |
Lidoderm | Phase 2 | Osteoarthritis, Knee | - | - |
Glycopyrronium MDI | Phase 2 | Asthma | - | - |
MAA868 Cohort 1 | Phase 2 | Atrial Fibrillation | - | - |
AVZO-103 | Phase 2 | Solid Tumor Cancer | - | - |
DAXI for injection 250 U | Phase 2 | Upper Limb Spasticity | - | - |
NMRA-335140 | Phase 2 | Major Depressive Disorder | - | - |
Nexagon® Low Dose | Phase 2 | Venous Leg Ulcers | - | - |
JP-1366 | Phase 2 | GERD | - | - |
T0903131 Besylate | Phase 2 | Diabetes Mellitus, Type II | - | - |
hPSC-CM Therapy | Phase 2 | Heart Failure | - | - |
SLS-002 | Phase 2 | Depressive Disorder, Major | - | - |
AVZO-1418 | Phase 2 | Solid Tumor Cancer | - | - |
Botulinum Toxin Type A | Phase 2 | Glabellar Frown Lines | - | - |
Aglatimagene besadenovec | Phase 2 | Borderline Resectable Pancreatic Adenocarcinoma | - | - |
EL219 | Phase 2 | Invasive Mould Infection | - | - |
Setanaxib | Phase 2 | Alport Syndrome | - | - |
H-1337 0.6% | Phase 2 | Glaucoma Open-Angle Primary | - | - |
EFB0027 (metformin delayed release) | Phase 2 | Type 2 Diabetes Mellitus | - | - |
50 mg Usnoflast | Phase 2 | Amyotrophic Lateral Sclerosis (ALS) | - | - |
AMT-116 | Phase 2 | Advanced Solid Tumors | - | - |
hI-con1 | Phase 2 | Choroidal Neovascularization | - | - |
BOLD-100 +/- FOLFOX Chemotherapy (Arm VII) | Phase 2 | Colorectal Cancer | - | - |
Rhu-pGSN | Phase 2 | Acute Respiratory Distress Syndrome | - | - |
MIN-102 | Phase 2 | Friedreich Ataxia | - | - |
AC-150 Combo | Phase 2 | Allergic Conjunctivitis | - | - |
ET140203 T Cells | Phase 2 | Hepatoblastoma | - | - |
TNP-2092 capsules | Phase 2 | Hyperammonemia | - | - |
Camidanlumab Tesirine | Phase 2 | Relapsed Hodgkin Lymphoma | - | - |
Met DR | Phase 2 | Type 2 Diabetes Mellitus | - | - |
INT131 besylate | Phase 2 | Type 2 Diabetes Mellitus | - | - |
FP01 | Phase 2 | Acute Cough | - | - |
TST001 | Phase 2 | Advanced Cancer | - | - |
pegylated IFNa2b | Phase 2 | Hepatitis C | - | - |
Linezolid | Phase 2 | Skin and Subcutaneous Tissue Bacterial Infections | - | - |
Tranilast | Phase 2 | Gout | - | - |
BC-819/PEI | Phase 2 | Superficial Bladder Cancer | - | - |
Faldaprevir | Phase 2 | Hepatitis C Viral Infection | - | - |
GKT137831 | Phase 2 | Type 2 Diabetes Mellitus With Diabetic Nephropathy | - | - |
ABT-301 | Phase 2 | Colorectal Cancer (Diagnosis) | - | - |
VB10.16 | Phase 2 | HPV Positive Oropharyngeal Squamous Cell Carcinoma | - | - |
AdVEGFXC1 | Phase 2 | Coronary Artery Disease | - | - |
ST-100 Ophthalmic Solution | Phase 2 | Dry Eye Disease | - | - |
RT001 (Botulinum Toxin Type A Topical Gel) | Phase 2 | Lateral Canthal Lines | - | - |
JTX-8064 | Phase 2 | Cancer | - | - |
ATI-450 | Phase 2 | Hidradenitis Suppurativa | - | - |
PTG-300 | Phase 2 | Polycythemia Vera | - | - |
Active | Phase 2 | Asthma | - | - |
PRTX007 | Phase 2 | Melanoma Stage III | - | - |
NAP (Naptumomab estafenatox) | Phase 2 | Non-small Cell Lung Cancer | - | - |
Ipamorelin | Phase 2 | Gastrointestinal Dysmotility | - | - |
MSDC-0602K | Phase 2 | Non-alcoholic Fatty Liver Disease | - | - |
25 mg Androxal | Phase 2 | Secondary Hypogonadism | - | - |
Testosterone undecanoate | Phase 2 | Hypogonadism | - | - |
Allo-QuadCAR01-T | Phase 2 | Lymphoma Diffuse Large B-cell | - | - |
188-0551 Solution | Phase 2 | Plaque Psoriasis | - | - |
IG3018 | Phase 2 | Hyperuricemia | - | - |
YL201 for Injection | Phase 2 | Advanced Solid Tumor | - | - |
5 mg Serlopitant Tablets | Phase 2 | Pruritus | - | - |
VLS-1488 | Phase 2 | Advanced Solid Tumor | - | - |
Halobetasol Propionate Lotion 0.05% | Phase 2 | Psoriasis | - | - |
octreotide acetate | Phase 2 | Acromegaly | - | - |
OPN-305 | Phase 2 | Myelodysplastic Syndrome | - | - |
Gene Therapy product:vMCO-I | Phase 2 | Retinitis Pigmentosa | - | - |
GFH018 | Phase 2 | NSCLC, Stage III | - | - |
Sevuparin | Phase 2 | Sickle-Cell Disease | - | - |
voretigene neparvovec-rzyl | Phase 2 | Leber Congenital Amaurosis | - | - |
AXS-12 (Reboxetine) | Phase 2 | Narcolepsy | - | - |
CB-03-01 | Phase 2 | Acne Vulgaris | - | - |
SRP1020 | Phase 2 | Advanced Solid Tumors | - | - |
Gene Therapy Product-MCO-010 | Phase 2 | Retinitis Pigmentosa | - | - |
Arm 1: SOC (mTOR + CNI) | Phase 2 | Kidney Transplantation | - | - |
Oral Testosterone Undecanoate | Phase 2 | Hypogonadism | - | - |
VK2735 | Phase 2 | Weight Loss | - | - |
Latanoprost | Phase 2 | Open-Angle Glaucoma | - | - |
UHE-105 | Phase 2 | Scalp Psoriasis | - | - |
Recombinant Human Plasma Gelsolin | Phase 2 | Community-acquired Pneumonia | - | - |
NT100 | Phase 2 | Repeated IVF Failure | - | - |
XOPH5 Ointment | Phase 2 | Lower Eyelid Steatoblepharon (Excess Eyelid Fat) | - | - |
ECT204 T cells | Phase 2 | Hepatocellular Carcinoma | - | - |
fludarabine phosphate | Phase 2 | Accelerated Phase Chronic Myelogenous Leukemia | - | - |
ABSK043 in combination with Glecirasib | Phase 2 | Non-Small Cell Lung Cancer | - | - |
RIST4721 | Phase 2 | Palmoplantar Pustulosis | - | - |
PT-112 | Phase 2 | Non-Small Cell Lung Cancer (NSCLC) | - | - |
TG-0054 combined with G-CSF | Phase 2 | Multiple Myeloma | - | - |
PTX-200 | Phase 2 | Acute Leukemia | - | - |
ABSK043 in combination with Firmonertinib | Phase 2 | Non-Small Cell Lung Cancer With EGFR Mutation | - | - |
trospium chloride inhalation powder (TrIP) | Phase 2 | Chronic Obstructive Pulmonary Disease | - | - |
Oral rsCT tablet | Phase 2 | Phase 1 Pharmacodynamic Study | - | - |
RNK05047 | Phase 2 | Advanced Solid Tumor | - | - |
12.5 mg Proellex | Phase 2 | Uterine Fibroids | - | - |
SRSD107 | Phase 2 | Coronary Artery Disease (CAD) | - | - |
SL-701; poly-ICLC (polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose) | Phase 2 | Adult Brain Glioblastoma | - | - |
Brepocitinib | Phase 2 | Dermatomyositis | - | - |
RAP-219 | Phase 2 | Focal Epilepsy | - | - |
PER-001 Intravitreal Implant - Low Dose | Phase 2 | Diabetic Retinopathy | - | - |
RNK08954 | Phase 2 | KRAS G12D Mutations | - | - |
DAXI 80 U | Phase 2 | Plantar Fasciitis | - | - |
DAXXIFY | Phase 2 | Glabellar Frown Lines | - | - |
Norketotifen | Phase 2 | Allergic Rhinitis | - | - |
LT3001 Drug Product | Phase 2 | Acute Ischemic Stroke | - | - |
ABX-002 | Phase 2 | Major Depressive Disorder | - | - |
ETX-018810 | Phase 2 | Diabetic Peripheral Neuropathic Pain | - | - |
ALT-100 mAb | Phase 2 | Acute Respiratory Distress Syndrome (ARDS) | - | - |
CT-868 | Phase 2 | Obesity | - | - |
JCARH125 | Phase 2 | Multiple Myeloma | - | - |
pTTL | Phase 2 | Colorectal Cancer | - | - |
AFNT-211 | Phase 2 | Pancreatic Ductal Adenocarcinoma | - | - |
RT001 Botulinum toxin type A (Dose A) | Phase 2 | Lateral Canthal Lines | - | - |
SM04554 | Phase 2 | Androgenetic Alopecia | - | - |
AHB-137 | Phase 2 | Hepatitis B, Chronic | - | - |
ANG003 Dose A | Phase 2 | Exocrine Pancreatic Insufficiency (EPI) | - | - |
AT-007 | Phase 2 | Classic Galactosemia | - | - |
SF0166 Topical Ophthalmic Solution | Phase 2 | Age-Related Macular Degeneration | - | - |
Eteplirsen | Phase 2 | Muscular Dystrophy, Duchenne | - | - |
Etavopivat | Phase 2 | Sickle Cell Disease | - | - |
ADX-629 | Phase 2 | Chronic Cough | - | - |
BTRX-246040 | Phase 2 | Parkinson Disease | - | - |
IMC-001 | Phase 2 | Extranodal NK/T-cell Lymphoma, Nasal Type | - | - |
RM-131 | Phase 2 | Constipation | - | - |
Enicepatide | Phase 2 | Obesity | - | - |
TT-034 | Phase 2 | Hepatitis C | - | - |
ARD-101 | Phase 2 | Bariatric Surgery | - | - |
CCH-aaes | Phase 2 | Edematous Fibrosclerotic Panniculopathy | - | - |
SM04690 | Phase 2 | Osteoarthritis | - | - |
Triac | Phase 2 | Allan-Herndon-Dudley Syndrome | - | - |
TG-0054 (2.24 mg/kg) | Phase 2 | Multiple Myeloma | - | - |
VSA006 | Phase 2 | Nash | - | - |
CTI-1601 | Phase 2 | Friedreich Ataxia | - | - |
Inhaled PT001 | Phase 2 | Chronic Obstructive Pulmonary Disease | - | - |
EHT102 Injection | Phase 2 | Treatment of Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF) | - | - |
HG004 | Phase 2 | Leber Congenital Amaurosis | - | - |
ABSK061 + ABSK043 | Phase 2 | HER2-Gastric/Gastroesophageal Junction Cancer | - | - |
Radezolid | Phase 2 | Community-Acquired Pneumonia (CAP) | - | - |
Tagraxofusp | Phase 2 | Acute Myeloid Leukemia | - | - |
QTORIN 3.9% rapamycin anhydrous gel | Phase 2 | Cutaneous Venous Malformations | - | - |
Bemarituzumab | Phase 2 | Gastric Cancer | - | - |
RZL-012+Lidacaine injection prior treatment | Phase 2 | Submental Fat | - | - |
ACER-801 50 mg BID | Phase 2 | Post-menopausal Vasomotor Symptoms | - | - |
AZD2115 Dose 1 | Phase 2 | Chronic Obstructive Pulmonary Disease (COPD) | - | - |
INT-210 Capsule | Phase 2 | Ulcerative Colitis (UC) | - | - |
SKP-1041 (experimental formulation of zaleplon) | Phase 2 | Sleep Disorder | - | - |
CT3001 | Phase 2 | Solid Tumor, Adult | - | - |
CT041 | Phase 2 | Gastric Cancer | - | - |
Saroglitazar | Phase 2 | Liver Transplant; Complications | - | - |
Bone marrow mesenchymal stem cells | Phase 2 | Osteoarthritis, Knee | - | - |
JPI-547 | Phase 2 | Pancreatic Ductal Adenocarcinoma | - | - |
Solabegron immediate release tablets, low dose | Phase 2 | Overactive Bladder | - | - |
Varenicline tartrate | Phase 2 | Trigeminal Neuralgia | - | - |
15mg T3D-959 | Phase 2 | Alzheimer Disease | - | - |
RZL-012 | Phase 2 | Submental Fat | - | - |
Solabegron modified release tablets, low dose | Phase 2 | Overactive Bladder | - | - |
Major Depressive Disorder
1 drug in this indication
Polycythemia Vera
1 drug in this indication
Psychosis Associated With Alzheimer's Disease
1 drug in this indication
Effect of Treatment on Bone Mineral Density
1 drug in this indication
Hidradenitis Suppurativa
1 drug in this indication
Source: CatalystAlert database (ClinicalTrials.gov, SEC EDGAR)
Full breakdown — the signals behind the verdict
Frequently asked questions
What is in TherapeuticsMD, Inc.'s drug pipeline?→
CatalystAlert tracks 306 drug candidates in TherapeuticsMD, Inc.'s (TXMD) pipeline across Phase 3, Phase 2. Its lead program is Factor VIII (rFVIIIFc) (Phase 3). Each drug's phase, indication and upcoming catalysts are listed on this page.
When is TherapeuticsMD, Inc.'s next FDA catalyst?→
TherapeuticsMD, Inc.'s (TXMD) next tracked catalyst is a Phase 2 expected August 15, 2026. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.
How do I track TXMD biotech catalysts?→
Add TXMD to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow TherapeuticsMD, Inc.'s live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.