Paroxysmal Nocturnal Hemoglobinuria

24
Pipeline Programs
10
Companies
28
Clinical Trials
7 recruiting
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
1
7
0
10
4
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
8100%
+ 16 programs with unclassified modality

On Market (4)

Approved therapies currently available

Apellis Pharmaceuticals
EMPAVELIApproved
pegcetacoplan
Apellis Pharmaceuticals
Complement Inhibitor [EPC]subcutaneous2021
Roche
PIASKYApproved
crovalimab
Roche
Complement C5 Inhibitor [EPC]intravenous2024
Apellis Pharmaceuticals
SYFOVREApproved
pegcetacoplan
Apellis Pharmaceuticals
Complement Inhibitor [EPC]intravitreal2023
Regeneron
VEOPOZApproved
pozelimab
Regeneron
Complement Inhibitor [EPC]injection2023

Competitive Landscape

10 companies ranked by most advanced pipeline stage

Regeneron
RegeneronTARRYTOWN, NY
5 programs
2
3
1
PozelimabPhase 3Monoclonal Antibody1 trial
PozelimabPhase 3Monoclonal Antibody1 trial
REGN3918Phase 32 trials
VEOPOZ(Pozelimab)Phase 2Monoclonal Antibody5 trials
PozelimabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT06028594No Longer Available
NCT07142343Recruiting5Est. Jan 2030
NCT05131204Terminated3Est. Jul 2023
+7 more trials
Apellis Pharmaceuticals
Apellis PharmaceuticalsAustralia - Hawthorn East
3 programs
1
2
1
APL-2Phase 31 trial
PegcetacoplanPhase 31 trial
PegcetacoplanPhase 11 trial
Active Trials
NCT02588833Completed23Est. Aug 2019
NCT04085601Completed53Est. Jun 2021
NCT03500549Completed80Est. Aug 2020
Roche
RocheSTAVANGER NORWAY, Norway
2 programs
2
1
CrovalimabPhase 3Monoclonal Antibody
CrovalimabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT04654468Active Not Recruiting51Est. Dec 2026
CP
Chugai PharmaJapan - Tokyo
2 programs
2
CrovalimabPhase 3Monoclonal Antibody1 trial
CrovalimabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT04434092Active Not Recruiting210Est. Sep 2027
NCT04432584Active Not Recruiting190Est. Sep 2027
Amgen
AmgenTHOUSAND OAKS, CA
1 program
1
ABP 959Phase 31 trial
Active Trials
NCT03818607Completed42Est. Jul 2022
BioCryst Pharmaceuticals
4 programs
1
1
2
BCX9930Phase 21 trial
BCX9930Phase 21 trial
BCX9930Phase 1/21 trial
BCX10013Phase 11 trial
Active Trials
NCT06100900Completed8Est. Dec 2024
NCT04330534Completed168Est. Jan 2021
NCT04702568Terminated19Est. Oct 2023
+1 more trials
Novartis
NovartisBASEL, Switzerland
3 programs
1
LFG316Phase 21 trial
PNH-relevant therapiesN/A1 trial
Specified Drug-use Surveillance of Fabhalta CapsulesN/A1 trial
Active Trials
NCT06411626Recruiting128Est. Jun 2026
NCT06606314Recruiting100Est. Sep 2028
NCT02534909Completed10Est. May 2022
NovelMed Therapeutics
NovelMed TherapeuticsOH - Cleveland
2 programs
2
NM8074Phase 21 trial
NM8074Phase 21 trial
Active Trials
NCT05646563Not Yet RecruitingEst. Jan 2028
NCT05646524Not Yet RecruitingEst. Sep 2028
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
Danicopan PMS in KoreaN/A1 trial
Active Trials
NCT07457151Not Yet Recruiting8Est. Jun 2028
Swedish Orphan Biovitrum
1 program
PegcetacoplanN/A1 trial
Active Trials
NCT05776472RecruitingEst. Aug 2029

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
RegeneronPozelimab
RegeneronPozelimab
RegeneronPozelimab
RegeneronPozelimab
RegeneronPozelimab
RocheCrovalimab
Chugai PharmaCrovalimab
Chugai PharmaCrovalimab
RegeneronREGN3918
Apellis PharmaceuticalsAPL-2
AmgenABP 959
Apellis PharmaceuticalsPegcetacoplan
NovelMed TherapeuticsNM8074
NovelMed TherapeuticsNM8074
BioCryst PharmaceuticalsBCX9930

Showing 15 of 27 trials with date data

Clinical Trials (28)

Total enrollment: 1,631 patients across 28 trials

A Study to Test the Safety of Pozelimab in Pediatric Participants 1 to 5 Years of Age With a Rare Disease Called CHAPLE (Complement Hyperactivation, Angiopathic Thrombosis, Protein-losing Enteropathy) Disease

Start: Mar 2026Est. completion: Jan 20305 patients
Phase 4Recruiting

A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Whose Current Treatment is Not Working Efficiently

Start: Mar 2026Est. completion: Sep 203135 patients
Phase 3Recruiting

A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works

Start: Mar 2023Est. completion: Feb 2029202 patients
Phase 3Recruiting

Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria

Start: Oct 2022Est. completion: Jul 20233 patients
Phase 3Terminated

A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment

Start: Aug 2022Est. completion: Jan 2027190 patients
Phase 3Recruiting

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition

Start: Mar 2021Est. completion: Dec 202651 patients
Phase 3Active Not Recruiting

A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors

Start: Oct 2020Est. completion: Sep 2027210 patients
Phase 3Active Not Recruiting

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

Start: Sep 2020Est. completion: Sep 2027190 patients
Phase 3Active Not Recruiting

REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate Its Long Term Safety, Efficacy and Tolerability.

Start: Dec 2019Est. completion: Apr 202224 patients
Phase 3Terminated

A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH

Start: Aug 2019Est. completion: Jun 202153 patients
Phase 3Completed

A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH

Start: Jan 2019Est. completion: Jul 202242 patients
Phase 3Completed

Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Start: Jun 2018Est. completion: Aug 202080 patients
Phase 3Completed

Study of Efficacy and Safety of NM8074 in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy

Start: Apr 2026Est. completion: Sep 2028
Phase 2Not Yet Recruiting

Study of NM8074 in Adult PNH Patients with Inadequate Response to Soliris

Start: Jan 2026Est. completion: Jan 2028
Phase 2Not Yet Recruiting

Long-term Safety of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria

Start: Jan 2023Est. completion: Jan 202528 patients
Phase 2Terminated

Pozelimab and Cemdisiran Combination Treatment in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy

Start: Jul 2021Est. completion: Oct 202324 patients
Phase 2Completed

Pozelimab and Cemdisiran Combination Therapy in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Switch From Eculizumab Therapy

Start: Jul 2021Est. completion: May 20236 patients
Phase 2Completed

A Long-Term Safety Study of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Start: Dec 2020Est. completion: Oct 202319 patients
Phase 2Terminated

Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Start: May 2019Est. completion: Jun 202124 patients
Phase 2Completed

Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Start: Sep 2015Est. completion: May 202210 patients
Phase 2Completed

First-in-Human Study of BCX9930 in Healthy Volunteers and Patients With PNH

Start: Mar 2020Est. completion: Jan 2021168 patients
Phase 1/2Completed

Dose Escalation of BCX10013 in Participants with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Start: Oct 2023Est. completion: Dec 20248 patients
Phase 1Completed

Pilot Study to Assess Safety, Preliminary Efficacy and Pharmacokinetics of S.C. Pegcetacoplan (APL-2) in PNH Subjects.

Start: Dec 2015Est. completion: Aug 201923 patients
Phase 1Completed

Compassionate Use of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria

N/ANo Longer Available
NCT07457151AstraZenecaDanicopan PMS in Korea

Danicopan PMS in Korea

Start: Mar 2026Est. completion: Jun 20288 patients
N/ANot Yet Recruiting
NCT06606314NovartisSpecified Drug-use Surveillance of Fabhalta Capsules

Specified Drug-use Surveillance of Fabhalta Capsules

Start: Sep 2024Est. completion: Sep 2028100 patients
N/ARecruiting
NCT06411626NovartisPNH-relevant therapies

Home Reported Outcomes in PNH

Start: Jun 2024Est. completion: Jun 2026128 patients
N/ARecruiting

A Real World Effectiveness Study of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Start: Jun 2023Est. completion: Aug 2029
N/ARecruiting

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

10 late-stage (Phase 3) programs — potential near-term approvals
7 actively recruiting trials targeting 1,631 patients
10 companies competing in this space