Bioequivalence

14
Pipeline Programs
12
Companies
14
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
14
0
0
0
0
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Teva
TevaIsrael - Petach Tikva
2 programs
2
Norethindrone/Ethinyl EstradiolPhase 11 trial
XM17Phase 11 trial
Active Trials
NCT01340625Completed36Est. Jan 2007
NCT02592031Completed49Est. Dec 2009
Pfizer
PfizerNEW YORK, NY
2 programs
2
Reference DrugPhase 11 trial
Test drugPhase 11 trial
Active Trials
NCT01260805Completed32Est. Oct 2010
NCT03821480Completed28Est. Mar 2019
Apollomics
ApollomicsFOSTER CITY, CA
1 program
1
APL-101Phase 11 trial
Active Trials
NCT05367388UnknownEst. Dec 2022
Coherus Oncology
Coherus OncologyCA - Redwood City
1 program
1
CHS-1701Phase 11 trial
Active Trials
NCT02385851Completed116Est. Jul 2015
Qilu Pharmaceutical
Qilu PharmaceuticalChina - Jinan
1 program
1
IS-5-MN RPhase 11 trial
Active Trials
NCT03557580CompletedEst. May 2018
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
1 program
1
KBP-5074 CapsulePhase 11 trial
Active Trials
NCT03340753Completed20Est. Dec 2017
Appili Therapeutics
1 program
1
Metronidazole TabletPhase 11 trial
Active Trials
NCT03337126Completed48Est. Dec 2017
Abbott
AbbottABBOTT PARK, IL
1 program
1
Moksi® 400mg TabletPhase 11 trial
Active Trials
NCT05307614Completed38Est. Apr 2019
Gedeon Richter
Gedeon RichterHungary - Budapest
1 program
1
RGB-02 or Neulasta®Phase 11 trial
Active Trials
NCT03146988Completed150Est. Oct 2017
H
HutchmedChina - Hong Kong
1 program
1
Savolitinib Test PreparationPhase 11 trial
Active Trials
NCT03860948Completed36Est. May 2019
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
1
Ticagrelor OD tabletPhase 11 trial
Active Trials
NCT02436577Completed51Est. Aug 2015
argenx
argenxBelgium - Zwijnaarde
1 program
1
efgartigimod PH20 SC as a prefilled syringe presentationPhase 11 trial
Active Trials
NCT05817435Completed120Est. May 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
argenxefgartigimod PH20 SC as a prefilled syringe presentation
ApollomicsAPL-101
HutchmedSavolitinib Test Preparation
AbbottMoksi® 400mg Tablet
PfizerTest drug
Qilu PharmaceuticalIS-5-MN R
Appili TherapeuticsMetronidazole Tablet
Novo NordiskKBP-5074 Capsule
Gedeon RichterRGB-02 or Neulasta®
AstraZenecaTicagrelor OD tablet
Coherus OncologyCHS-1701
PfizerReference Drug
TevaXM17
TevaNorethindrone/Ethinyl Estradiol

Clinical Trials (14)

Total enrollment: 724 patients across 14 trials

NCT05817435argenxefgartigimod PH20 SC as a prefilled syringe presentation

A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults

Start: Mar 2023Est. completion: May 2023120 patients
Phase 1Completed
NCT05367388ApollomicsAPL-101

A Study Comparing Two Different Capsules, APL-101 and PLB-1001 Capsules, in Healthy Chinese and Caucasian Participants

Start: May 2022Est. completion: Dec 2022
Phase 1Unknown
NCT03860948HutchmedSavolitinib Test Preparation

A Pharmacokinetic and Bioequivalence Study of Savolitinib Tablets in Healthy Chinese Male Volunteers

Start: Apr 2019Est. completion: May 201936 patients
Phase 1Completed
NCT05307614AbbottMoksi® 400mg Tablet

Bioequivalence Study of Moksi® 400mg Tablet and Avelox® 400mg Tablet (Moxifloxacin) Under Fasting Condition in Healthy Adult Pakistani Subjects

Start: Mar 2019Est. completion: Apr 201938 patients
Phase 1Completed
NCT03821480PfizerTest drug

Diflucan Bioequivalence Study For Transferring The Manufacture

Start: Jan 2019Est. completion: Mar 201928 patients
Phase 1Completed
NCT03557580Qilu PharmaceuticalIS-5-MN R

A Bioequivalence Study of Isosorbide-5-Mononitrate Extended-Release Tablets Under Fed Conditions in Healthy Subjects

Start: Apr 2018Est. completion: May 2018
Phase 1Completed
NCT03337126Appili TherapeuticsMetronidazole Tablet

Bioavailability of ATI-1501 With Taste Test Sub Study

Start: Nov 2017Est. completion: Dec 201748 patients
Phase 1Completed
NCT03340753Novo NordiskKBP-5074 Capsule

Bioavailability of KBP-5074 Tablet vs Capsule Formulations

Start: Oct 2017Est. completion: Dec 201720 patients
Phase 1Completed
NCT03146988Gedeon RichterRGB-02 or Neulasta®

Study to Compare the Pharmacokinetics and Pharmacodynamics of 6 mg RGB-02 to 6 mg Neulasta

Start: Apr 2017Est. completion: Oct 2017150 patients
Phase 1Completed
NCT02436577AstraZenecaTicagrelor OD tablet

Study to Assess the Bioequivalence Between Ticagrelor Orodispersible Tablets and Ticagrelor Immediate-release Tablets in Japanese Subjects

Start: Jun 2015Est. completion: Aug 201551 patients
Phase 1Completed
NCT02385851Coherus OncologyCHS-1701

Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim)

Start: Feb 2015Est. completion: Jul 2015116 patients
Phase 1Completed
NCT01260805PfizerReference Drug

A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers.

Start: Sep 2010Est. completion: Oct 201032 patients
Phase 1Completed
NCT02592031TevaXM17

Study to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women

Start: Feb 2009Est. completion: Dec 200949 patients
Phase 1Completed
NCT01340625TevaNorethindrone/Ethinyl Estradiol

Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions

Start: Dec 2006Est. completion: Jan 200736 patients
Phase 1Completed

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

12 companies competing in this space