Nuzyra

(Omadacycline)

ApprovedSmall molecule

PParatek Pharmaceuticals Inc

Nuzyra is one of 119 small molecule programs targeting Cystic Fibrosis. It is currently in Approved.

Indications

Total Trials

Active Trials

118

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Cystic FibrosisCompleted

Mycoplasma GenitaliumNot yet recruiting

Safety and EfficacyRecruiting

Diabetic FootActive, not recruiting

Cystic FibrosisApproved

Completed

Mycoplasma GenitaliumPhase 2

Not yet recruiting

Safety and EfficacyPhase 3

Recruiting

Diabetic FootPreclinical

Active, not recruiting

Competition

Competitive Landscape

130 competitors in Safety and Efficacy

#DrugCompanyPhaseTrials

Avastin

Roche

Phase 3

3 2

Nuzyra

PParatek Pharmaceuticals Inc

Approved

1 3

Actemra

Roche

Phase 3

1 4

Humira

RRanbaxy Laboratories Limited

Phase 3

3 5

Rayos

RRoxane Laboratories

Phase 3

3 6

Empaveli

Apellis Pharmaceuticals

Phase 3

2 7

CAB LA

GSK

Phase 3

1 8

Tagrisso

AstraZeneca

Phase 2

3 9

B/F/TAF

Gilead

Phase 3

5 10

Trodelvy

Gilead

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 2Not yet recruiting

Mycoplasma Genitalium

NCT07853742

Clinical

Trials by Indication[1]

Treatment3 trials

Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)

Completed·PParatek Pharmaceuticals Inc·Phase 3·NCT02531438·774 enrolled

Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

Completed·PParatek Pharmaceuticals Inc·Phase 3·NCT02877927·735 enrolled

Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)

Completed·PParatek Pharmaceuticals Inc·Phase 3·NCT02378480·655 enrolled

Bacterial Pneumonia2 trials

Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia

Completed·PParatek Pharmaceuticals Inc·Phase 1·NCT04160260·18 enrolled

Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia

Completed·PParatek Pharmaceuticals Inc·Phase 3·NCT04779242·670 enrolled

Diabetic Foot1 trial

Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis

Recruiting·MMethodist Health System··NCT04714411·600 enrolled

Wound Infection1 trial

Omadacycline Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

Completed·HHartford Hospital·Phase 1·NCT04144374·14 enrolled

Adult1 trial

A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers

Completed·ZZai Lab (Hong Kong), Ltd.·Phase 1·NCT06462326·24 enrolled

9 more indications

Cystitis1 trial

Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis

Completed·PParatek Pharmaceuticals Inc·Phase 2·NCT03425396·225 enrolled

Abscess1 trial

Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)

Completed·PParatek Pharmaceuticals Inc·Phase 2·NCT04922554·66 enrolled

Bacterial Infections1 trial

Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections

Completed·PParatek Pharmaceuticals Inc·Phase 1·NCT05217537·23 enrolled

Gut Microbiome1 trial

Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Completed·WWake Forest University Health Sciences·Phase 4·NCT05515562·8 enrolled

Cystic Fibrosis1 trial

Pharmacokinetics of Omadacycline in Cystic Fibrosis

Completed·PPaul Beringer·Phase 4·NCT04460586·9 enrolled

Safety and Efficacy1 trial

A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP

Recruiting·ZZai Lab (Hong Kong), Ltd.·Phase 3·NCT06162286·100 enrolled

Pyelonephritis1 trial

IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis

Completed·PParatek Pharmaceuticals Inc·Phase 2·NCT03757234·201 enrolled

Mycoplasma Genitalium1 trial

Omadacycline for Treatment Refractory Mycoplasma Genitalium Urethritis

Not yet recruiting·MMontefiore Medical Center·Phase 2·NCT07853742·10 enrolled

Unspecified1 trial

Microbiome Effect of Omadacycline on Healthy Volunteers

Completed·UUniversity of Houston·Phase 1·NCT06030219·32 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 2, 2018

NUZYRA

NDA NDA209817

Oct 2, 2018

NUZYRA

NDA NDA209816

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Omadacycline. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Omadacycline compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Omadacycline. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209817). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Nuzyra. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Paratek Pharmaceuticals Inc company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: PParatek Pharmaceuticals Inc

Patent Landscape[5]

Patent Cliff

Mar 5, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10124014Mar 5, 2029

9724358Mar 5, 2029

8383610Sep 23, 2030

9265740Oct 24, 2030

9314475Mar 18, 2031

3 more patents

10111890Aug 3, 2037

10835542Oct 31, 2037

10383884Oct 31, 2037

Nuzyra

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Trials by Indication[1]

Treatment3 trials

Bacterial Pneumonia2 trials

Diabetic Foot1 trial

Wound Infection1 trial

Adult1 trial

Cystitis1 trial

Abscess1 trial

Bacterial Infections1 trial

Gut Microbiome1 trial

Cystic Fibrosis1 trial

Safety and Efficacy1 trial

Pyelonephritis1 trial

Mycoplasma Genitalium1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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