Preterm Birth

Pipeline Programs

Companies

Clinical Trials

4 recruiting

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

RNA Therapeutic

1100%

+ 31 programs with unclassified modality

Competitive Landscape

14 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

Human BioSciencesWV - Martinsburg

13 programs

Vaginal ProgesteronePhase 41 trial

17 alpha-hydroxyprogesterone caproatePhase 31 trial

NIDCAPPhase 21 trial

17-Hydroxyprogesterone caproate 250mg or 500 mg.Phase 1/21 trial

Daily aspirinPhase 1/21 trial

+8 more programs

Active Trials

NCT07231432Active Not Recruiting190Est. Dec 2028

NCT05756634Completed67Est. Oct 2025

NCT04247555Unknown270Est. Mar 2022

+10 more trials

March BiosciencesTX - Houston

3 programs

Docosahexaenoic Acid + Arachidonic AcidPhase 41 trial

CellulaR Injury and Preterm BirthN/A1 trial

The Biomarker StudyN/A1 trial

Active Trials

NCT02441335Completed705Est. Aug 2019

NCT01148654Completed1,076Est. Jun 2012

NCT01576783Completed377Est. Apr 2017

Colorado TherapeuticsCO - Louisville

2 programs

Oral nitrofurantoin monohydrate/macrocrystalsPhase 31 trial

Increasing use of Antenatal CorticosteroidsN/A1 trial

Active Trials

NCT01084096Completed103,117Est. Apr 2014

NCT06723392Recruiting1,134Est. Nov 2028

Pediatrix TherapeuticsChina - Shanghai

3 programs

17-alpha-hydroxyprogesterone caproate injectablePhase 2/31 trial

Cervical Cerclage placementPhase 2/31 trial

VF-TestN/A

Active Trials

NCT00163020Completed321Est. Aug 2009

NCT03077633Withdrawn0Est. Jan 2018

PhilipsNetherlands - Amsterdam

2 programs

NICU DashboardN/A1 trial

Active Trials

NCT03673579Withdrawn0Est. Apr 2020

NCT03673566Withdrawn0Est. Apr 2020

Angeles TherapeuticsCA - Los Angeles

1 program

CenteringPregnancyN/A1 trial

Active Trials

NCT04097548Completed1,133Est. Mar 2023

BayerLEVERKUSEN, Germany

1 program

Direct Measurements of Cervical Remodeling for Predicting Preterm BirthN/A1 trial

Active Trials

NCT01175551Completed1,207Est. May 2012

LabcorpBURLINGTON, NC

1 program

Nurse-Family PartnershipN/A1 trial

Active Trials

NCT03360539Active Not Recruiting5,670Est. Apr 2046

UNION therapeuticsDenmark - Hellerup

1 program

Preterm Birth Prediction by Measurement of Biomarkers in Cervical Vaginal FluidN/A1 trial

Active Trials

NCT03974724Unknown5,000Est. Aug 2022

Shield TherapeuticsMA - Wellesley

1 program

Targeted Nurse Home VisitsN/A1 trial

Active Trials

NCT00502697Completed236Est. Dec 2012

PfizerNEW YORK, NY

1 program

Triadic parent-infant Relationship TherapyN/A1 trial

Active Trials

NCT02394444Completed89Est. Feb 2010

HologicMARLBOROUGH, MA

1 program

VF-TestN/A1 trial

Active Trials

NCT03443154Withdrawn0Est. Jun 2018

Juniper BiosciencesNJ - Bridgewater

1 program

Vaginal progesterone gelN/A1 trial

Active Trials

NCT00343265Completed84Est. Mar 2011

Hamilton medicalSwitzerland - Bonaduz

1 program

Celestone + placeboPHASE_41 trial

Active Trials

NCT05114096Recruiting3,254Est. Dec 2029

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

2027

2028

2029

2030

2031

Hamilton medicalCelestone + placebo

Human BioSciencesVaginal Progesterone

March BiosciencesDocosahexaenoic Acid + Arachidonic Acid

Colorado TherapeuticsOral nitrofurantoin monohydrate/macrocrystals

Human BioSciences17 alpha-hydroxyprogesterone caproate

Pediatrix TherapeuticsCervical Cerclage placement

Pediatrix Therapeutics17-alpha-hydroxyprogesterone caproate injectable

Human BioSciencesNIDCAP

Human BioSciencesDaily aspirin

Human BioSciences17-Hydroxyprogesterone caproate 250mg or 500 mg.

Human BioSciencesBehavioral Interventions

Human BioSciencesImplementation of social determinants of health screening and referral

Human BioSciencesFinancial Transfers

Human BioSciencesCare Coordination after Preterm Birth

Human BioSciencesDocosahexaenoic Acid + Arachidonic Acid

Showing 15 of 31 trials with date data

Clinical Trials (31)

Total enrollment: 134,431 patients across 31 trials

NCT05114096 Hamilton medicalCelestone + placebo

Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)

Start: Jul 2023Est. completion: Dec 20293,254 patients

Phase 4Recruiting

NCT02970552 Human BioSciencesVaginal Progesterone

Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth

Start: Jul 2017Est. completion: Nov 2018140 patients

Phase 4Completed

NCT01576783 March BiosciencesDocosahexaenoic Acid + Arachidonic Acid

Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes

Start: Apr 2012Est. completion: Apr 2017377 patients

Phase 4Completed

NCT06723392 Colorado TherapeuticsOral nitrofurantoin monohydrate/macrocrystals

Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries

Start: Dec 2025Est. completion: Nov 20281,134 patients

Phase 3Recruiting

NCT00099164 Human BioSciences17 alpha-hydroxyprogesterone caproate

Trial of Progesterone in Twins and Triplets to Prevent Preterm Birth (STTARS)

Start: Apr 2004Est. completion: Sep 2007795 patients

Phase 3Completed

NCT03077633 Pediatrix TherapeuticsCervical Cerclage placement

Cerclage for Twins With Short Cervix

Start: Oct 2017Est. completion: Jan 20180

Phase 2/3Withdrawn

NCT00163020 Pediatrix Therapeutics17-alpha-hydroxyprogesterone caproate injectable

17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies

Start: Nov 2004Est. completion: Aug 2009321 patients

Phase 2/3Completed

NCT00166660 Human BioSciencesNIDCAP

Preterm Fetal Growth Restriction and Developmental Care

Start: Jul 2004Est. completion: Jun 200930 patients

Phase 2Unknown

NCT06826859 Human BioSciencesDaily aspirin

Daily Aspirin vs Split Dosing in High-risk Pregnancies (DASH)

Start: Jun 2025Est. completion: Dec 2029400 patients

Phase 1/2Recruiting

NCT03292731 Human BioSciences17-Hydroxyprogesterone caproate 250mg or 500 mg.

Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth

Start: Feb 2018Est. completion: Sep 2021159 patients

Phase 1/2Terminated

NCT07231432 Human BioSciencesBehavioral Interventions

Promoting Kangaroo Care for Preterm or Low Birthweight Infants in Rural India

Start: Jun 2025Est. completion: Dec 2028190 patients

N/AActive Not Recruiting

NCT06582147 Human BioSciencesImplementation of social determinants of health screening and referral

The Social Determinants of Health Screening and Referral Project

Start: Dec 2024Est. completion: Dec 2027882 patients

N/AEnrolling By Invitation

NCT06362798 Human BioSciencesFinancial Transfers

Effect of Support for Low-Income Mothers of Preterm Infants

Start: Oct 2024Est. completion: Aug 2028420 patients

N/ARecruiting

NCT05756634 Human BioSciencesCare Coordination after Preterm Birth

Health and Wellness After Preterm Birth

Start: Jul 2023Est. completion: Oct 202567 patients

N/ACompleted

NCT05191823 Human BioSciencesDocosahexaenoic Acid + Arachidonic Acid

Omega Tots Long Term Follow-up

Start: Dec 2021Est. completion: Jun 2026377 patients

N/AEnrolling By Invitation

NCT04247555 Human BioSciencesCervix Monitor for Detection Conditions Leading to Spontaneous Preterm Delivery

Cervix Monitor for Detection Conditions Leading to Spontaneous Preterm Delivery

Start: Jan 2020Est. completion: Mar 2022270 patients

N/AUnknown

NCT03974724 UNION therapeuticsPreterm Birth Prediction by Measurement of Biomarkers in Cervical Vaginal Fluid

Preterm Birth Prediction by Measurement of Biomarkers in Cervical Vaginal Fluid

Start: May 2019Est. completion: Aug 20225,000 patients

N/AUnknown

NCT03673566 PhilipsNICU Dashboard

Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO

Start: Mar 2019Est. completion: Apr 20200

N/AWithdrawn

NCT04097548 Angeles TherapeuticsCenteringPregnancy

A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation

Start: Aug 2018Est. completion: Mar 20231,133 patients

N/ACompleted

NCT03673579 PhilipsNICU Dashboard

Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB

Start: Jun 2018Est. completion: Apr 20200

N/AWithdrawn

NCT03443154 HologicVF-Test

VF Test for Prediction of Extremely PTB After Cerclage

Start: Jun 2018Est. completion: Jun 20180

N/AWithdrawn

NCT03360539 LabcorpNurse-Family Partnership

Nurse-Family Partnership Impact Evaluation in South Carolina

Start: Apr 2016Est. completion: Apr 20465,670 patients

N/AActive Not Recruiting

NCT02441335 March BiosciencesCellulaR Injury and Preterm Birth

CellulaR Injury and Preterm Birth

Start: Jan 2015Est. completion: Aug 2019705 patients

N/ACompleted

NCT02139800 Human BioSciencesSustained Inflation

Sustained Aeration of Infant Lungs Trial

Start: Aug 2014Est. completion: Mar 2020460 patients

N/ACompleted

NCT01084096 Colorado TherapeuticsIncreasing use of Antenatal Corticosteroids

Trial of the Use of Antenatal Corticosteroids in Developing Countries

Start: Oct 2011Est. completion: Apr 2014103,117 patients

N/ACompleted

NCT01175551 BayerDirect Measurements of Cervical Remodeling for Predicting Preterm Birth

Direct Measurements of Cervical Remodeling for Predicting Preterm Birth

Start: Nov 2009Est. completion: May 20121,207 patients

N/ACompleted

NCT01148654 March BiosciencesThe Biomarker Study

The Biomarker Study

Start: May 2008Est. completion: Jun 20121,076 patients

N/ACompleted

NCT00502697 Shield TherapeuticsTargeted Nurse Home Visits

Tennessee Connections for Better Birth Outcomes

Start: Nov 2006Est. completion: Dec 2012236 patients

N/ACompleted

NCT00343265 Juniper BiosciencesVaginal progesterone gel

Vaginal Progesterone Versus Placebo in Multiple Pregnancy

Start: Jun 2006Est. completion: Mar 201184 patients

N/ACompleted

NCT02394444 PfizerTriadic parent-infant Relationship Therapy

Impact of an Intervention Program on Parenting Stress After Preterm Birth

Start: Jun 2006Est. completion: Feb 201089 patients

N/ACompleted

NCT00342277 Human BioSciencesMicroarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition

Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition

Start: Dec 1999Est. completion: May 20166,838 patients

N/ACompleted

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

2 late-stage (Phase 3) programs, potential near-term approvals

4 actively recruiting trials targeting 134,431 patients

14 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.