Symproic

(Naldemedine)

ApprovedSmall molecule

BBioDelivery Sciences International

Symproic is one of 64 small molecule programs targeting Acute Pancreatitis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Acute PancreatitisActive, not recruiting

Nausea and VomitingActive, not recruiting

Opioid-Induced Constipation (OIC)Recruiting

Acute PancreatitisPhase 3

Active, not recruiting

Nausea and VomitingApproved

Active, not recruiting

Opioid-Induced Constipation (OIC)Preclinical

Recruiting

Competition

Competitive Landscape

78 competitors in Nausea and Vomiting

#DrugCompanyPhaseTrials

Zofran

Novartis

Approved

63 2

Ketalar

AAultman Health Foundation

Approved

2 3

Marcaine

IInnocoll

Approved

1 4

Thalomid

Bristol-Myers Squibb

Phase 3

2 5

Megace

Bristol-Myers Squibb

Phase 3

1 6

Abraxane

Bristol-Myers Squibb

Phase 3

1 7

Gemzar

Johnson & Johnson

Phase 3

1 8

Symproic

BBioDelivery Sciences International

Approved

1 9

Nereus

VVanda Pharmaceuticals

Phase 3

2 10

HSK21542

Haisco Pharmaceutical Group Co., Ltd.

Phase 3

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

Timeline

Expected Milestones

Q3 2027

Post-ApprovalRecruiting

Nausea and Vomiting

NCT07038551

Q2 2028

PreclinicalRecruiting

Opioid-Induced Constipation (OIC)

NCT05588323

Q2 2029

Recruiting

Opioid-Induced Constipation

NCT03720613

Clinical

Trials by Indication[1]

Chronic pain2 trials

Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain

Completed· Shionogi logo

Shionogi·Phase 2·NCT01122030·72 enrolled

A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy

Completed· Shionogi logo

Shionogi·Phase 2·NCT01443403·244 enrolled

Constipation2 trials

Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation

Completed· Shionogi logo

Shionogi·Phase 3·NCT01993940·553 enrolled

Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation

Completed· Shionogi logo

Shionogi·Phase 3·NCT01965158·547 enrolled

ART1 trial

A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection

Terminated· Shionogi logo

Shionogi·Phase 2·NCT04355169·2 enrolled

ALD1 trial

Long Term Safety of Naldemedine

Completed· Shionogi logo

Shionogi·Phase 3·NCT01965652·1,246 enrolled

Nausea and vomiting1 trial

Prophylactic Use of Naldemedine on Opioid-induced Nausea and Vomiting in Patients With Cancer: POSEIDON Study

Recruiting·IInternational University of Health and Welfare·Phase 4·NCT07038551·120 enrolled

4 more indications

Function1 trial

The Effect of Naldemedine on Opioid-induced Bowel Dysfunction

Recruiting·AAsbjørn Mohr Drewes·Phase 2·NCT06334198·20 enrolled

Acute Pancreatitis1 trial

Effects of a Peripherally Acting µ-opioid Receptor Antagonist on Recurrent Acute Pancreatitis

Active, not recruiting·AAsbjørn Mohr Drewes·Phase 2/3·NCT04966559·74 enrolled

Opioid-Induced Constipation1 trial

Risk of Major Adverse Cardiovascular Events Among Users of Naldemedine Compared With Other Medications Used for Opioid Induced Constipation in Adult Patients With Chronic Non-Cancer Pain in a Healthcare Claims Database

Recruiting·BBioDelivery Sciences International··NCT03720613·34,532 enrolled

Opioid-Induced Constipation (OIC)1 trial

A Phase 1/2, Multicentre, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric Patients Who Are Receiving or Who Are About to Receive Treatment With Opioids

Recruiting· Shionogi logo

Shionogi·Preclinical·NCT05588323·24 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 23, 2017

SYMPROIC

NDA NDA208854

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Naldemedine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Naldemedine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Naldemedine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208854). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Symproic. U.S. Food & Drug Administration.
[6]
SEC EDGAR — BioDelivery Sciences International company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: BBioDelivery Sciences International

Patent Landscape[5]

Patent Cliff

Feb 24, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE46375Oct 5, 2026

RE46365Feb 24, 2031

9108975Nov 11, 2031

10952968May 13, 2033

12350377May 13, 2033

Symproic

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q2 2028

Q2 2029

Trials by Indication[1]

Chronic pain2 trials

Constipation2 trials

ART1 trial

ALD1 trial

Nausea and vomiting1 trial

Function1 trial

Acute Pancreatitis1 trial

Opioid-Induced Constipation1 trial

Opioid-Induced Constipation (OIC)1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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