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[{"orgOrder":0,"company":"Trevi Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Trevi Therapeutics Provides Clinical Trial Updates for Haduvio\u2122","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Lumosa Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LT1001 (Naldebain(R)), an Extended-Release Analgesic Injection, Received Its Second Approval from Singapore's HSA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"TAIWAN","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Trevi Therapeutics","sponsor":"Stifel","pharmaFlowCategory":"D","amount":"$11.8 million","upfrontCash":"Undisclosed","newsHeadline":"Trevi Therapeutics Announces $11.8 Million Private Placement Priced At-the-Market","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Trevi Therapeutics","sponsor":"Frazier Life Sciences","pharmaFlowCategory":"D","amount":"$55.0 million","upfrontCash":"Undisclosed","newsHeadline":"Trevi Therapeutics Announces $55 Million Private Placement Priced At-the-Market","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Trevi Therapeutics","sponsor":"SVB Securities","pharmaFlowCategory":"D","amount":"$55.0 million","upfrontCash":"Undisclosed","newsHeadline":"Trevi Therapeutics Announces Pricing of $55 Million Public Offering","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Trevi Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Trevi Therapeutics Completes Enrollment for Phase 2b\/3 PRISM Study in Chronic Pruritus in PN","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Trevi Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Trevi Therapeutics Reports Statistically Significant Result on Interim Analysis from the Ph2 CANAL Trial of Nalbuphine ER in the Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Trevi Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Trevi Therapeutics Concludes Enrollment for Phase 2 CANAL Trial in IPF Chronic Cough","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Trevi Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Trevi Therapeutics Reports Positive Results from the Ph2b\/3 PRISM Trial of Haduvio\u2122 in the Treatment of Prurigo Nodularis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Trevi Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Trevi Therapeutics Announces Multiple Late-Breaking Abstracts Accepted for Presentation at Upcoming Medical Conferences on Analysis of Oral Nalbuphine Extended Release","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Trevi Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Trevi Therapeutics Announces the Initiation of its Phase 2a RIVER Clinical Trial of Haduvio\u2122 for Refractory Chronic Cough","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"}]
Find Clinical Drug Pipeline Developments & Deals for Nalbuphine
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Companies By Therapeutic Area
Details:
Haduvio (oral nalbuphine ER) is a centrally and peripherally acting investigational therapy which is under phase 2 clinical development for the treatment of refractory chronic cough (RCC).
Lead Product(s):
Nalbuphine Hydrochloride
Therapeutic Area: Pulmonary/Respiratory Diseases
Product Name: Haduvio
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
November 02, 2023
Details:
The company will use the net proceeds from the offering for the development of clinical pipeline including its lead product Haduvio (nalbuphine) and for other general and corporate purpose.
Lead Product(s):
Nalbuphine Hydrochloride
Therapeutic Area: Pulmonary/Respiratory Diseases
Product Name: Haduvio
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
SVB Securities
Deal Size: $55.0 million
Upfront Cash: Undisclosed
Deal Type: Public Offering
September 23, 2022
Details:
Primary efficacy endpoint demonstrated 77.3% reduction in daytime cough frequency from baseline with use of Haduvio (nalbuphine ER) compared to 25.7% reduction with placebo, 52% placebo-adjusted reduction in geometric mean percent change in daytime cough frequency (p<0.0001).
Lead Product(s):
Nalbuphine Hydrochloride
Therapeutic Area: Dermatology
Product Name: Haduvio
Highest Development Status: Phase II/ Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
August 24, 2022
Details:
Haduvio (oral nalbuphine ER) demonstrated statistically significant results on the primary efficacy endpoint as measured by a 4-point reduction in the Worst Itch – Numerical Rating Scale (WI-NRS) (p=0.0157).
Lead Product(s):
Nalbuphine Hydrochloride
Therapeutic Area: Dermatology
Product Name: Haduvio
Highest Development Status: Phase II/ Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 29, 2022
Details:
Company intends to use net proceeds from the private placement for the clinical development of Haduvio (Nalbuphine ER), a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist for chronic cough in IPF and working capital and other general corporate purposes.
Lead Product(s):
Nalbuphine Hydrochloride
Therapeutic Area: Pulmonary/Respiratory Diseases
Product Name: Haduvio
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Frazier Life Sciences
Deal Size: $55.0 million
Upfront Cash: Undisclosed
Deal Type: Private Placement
April 07, 2022
Details:
The primary efficacy endpoint demonstrated a 77.3% reduction in daytime cough frequency from baseline with use of Haduvio compared to a 25.7% reduction with placebo, demonstrating a 52% placebo-adjusted reduction in geometric mean percent change in daytime cough frequency.
Lead Product(s):
Nalbuphine Hydrochloride
Therapeutic Area: Pulmonary/Respiratory Diseases
Product Name: Haduvio
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 15, 2022
Details:
Interim analysis showed primary efficacy endpoint of cough reduction was highly statistically significant (p<0.0001) for Haduvio (nalbuphine ER) in idiopathic pulmonary fibrosis patients (IPF) suffering from chronic cough, establishing proof of concept.
Lead Product(s):
Nalbuphine Hydrochloride
Therapeutic Area: Pulmonary/Respiratory Diseases
Product Name: Haduvio
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 26, 2022
Details:
Phase 2b/3 PRISM trial enrollment completed for Haduvio (nalbuphine ER), mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist for the treatment of pruritus associated with prurigo nodularis.
Lead Product(s):
Nalbuphine Hydrochloride
Therapeutic Area: Dermatology
Product Name: Haduvio
Highest Development Status: Phase II/ Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 01, 2022
Details:
The Company will use the net proceeds from the private placement for the development of an investigational therapy Haduvio™, an oral extended-release (ER) formulation of nalbuphine to treat serious neurologically mediated conditions.
Lead Product(s):
Nalbuphine Hydrochloride
Therapeutic Area: Dermatology
Product Name: Haduvio
Highest Development Status: Phase II/ Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Stifel
Deal Size: $11.8 million
Upfront Cash: Undisclosed
Deal Type: Private Placement
September 30, 2021
Details:
LT1001 is the world's first week-long extended-release analgesic injection. The approval from Singapore has significance in accelerating the introduction of LT1001 in Southeast Asia.
Lead Product(s):
Nalbuphine Hydrochloride
Therapeutic Area: Neurology
Product Name: LT1001
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
December 21, 2020