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NEWS #PharmaBuzz
14 Aug 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/norgine-completes-acquisition-of-theravia-302529332.html
09 Jul 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/swissmedic-approves-ifinwil-eflornithine-for-children-diagnosed-with-high-risk-neuroblastoma-hrnb-302499271.html
17 Apr 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/norgine-welcomes-tga-registration-in-australia-of-ifinwil-eflornithine-for-adults-and-children-diagnosed-with-high-risk-neuroblastoma-hrnb1-302430883.html
15 Apr 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/norgine-strengthens-rare-disease-portfolio-with-acquisition-of-theravia-302427963.html
24 Jan 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/x4-pharmaceuticals-announces-ema-validation-of-marketing-authorization-application-maa-for-mavorixafor---licenced-to-norgine-for-commercialisation-in-europe-302359812.html
13 Jan 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/01/13/3008383/0/en/X4-Pharmaceuticals-and-Norgine-Enter-into-Exclusive-Licensing-Agreement-to-Commercialize-Mavorixafor-in-Europe-Australia-and-New-Zealand.html
Drugs in Development
Details:
Plenvu (Polyethylene Glycol 3350) is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Gastrointestinal Diseases.
Lead Product(s): Polyethylene Glycol 3350,Ascorbic Acid,Potassium Chloride,Sodium Ascorbate,Sodium Chloride
Therapeutic Area: Gastroenterology Brand Name: Plenvu
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: PAREXEL International Corporation
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 20, 2025
Lead Product(s) : Polyethylene Glycol 3350,Ascorbic Acid,Potassium Chloride,Sodium Ascorbate,Sodium Chloride
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : PAREXEL International Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
PLENVU vs Sodium Picosulfate for Bowel Cleansing in Children
Details : Plenvu (Polyethylene Glycol 3350) is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Gastrointestinal Diseases.
Product Name : Plenvu
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 20, 2025
Details:
Through the acquisition, Norgine will have six core products in its rare disease portfolio, which includes Siklos (hydroxyurea) is being indicated for the treatment of sickle cell anemia.
Lead Product(s): Hydroxyurea,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Siklos
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Recipient: Theravia
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition August 14, 2025
Lead Product(s) : Hydroxyurea,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Recipient : Theravia
Deal Size : Undisclosed
Deal Type : Acquisition
Norgine completes acquisition of Theravia
Details : Through the acquisition, Norgine will have six core products in its rare disease portfolio, which includes Siklos (hydroxyurea) is being indicated for the treatment of sickle cell anemia.
Product Name : Siklos
Product Type : Cytotoxic Drug
Upfront Cash : Undisclosed
August 14, 2025
Details:
Ifinwil (eflornithine) is a TGA approved ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma.
Lead Product(s): Eflornithine Hydrochloride,Inapplicable
Therapeutic Area: Oncology Brand Name: Ifinwil
Study Phase: Approved FDFProduct Type: Amino Acid
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 17, 2025
Lead Product(s) : Eflornithine Hydrochloride,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Norgine gets Australia TGA Approval for IFINWIL in High-Risk Neuroblastoma
Details : Ifinwil (eflornithine) is a TGA approved ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma.
Product Name : Ifinwil
Product Type : Amino Acid
Upfront Cash : Inapplicable
April 17, 2025
Details:
Through the acquisition, Norgine will have six core products in its rare disease portfolio, which includes Siklos (hydroxyurea) is being indicated for the treatment of sickle cell anemia.
Lead Product(s): Hydroxyurea,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Siklos
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Recipient: Theravia
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition April 15, 2025
Lead Product(s) : Hydroxyurea,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Recipient : Theravia
Deal Size : Undisclosed
Deal Type : Acquisition
Norgine Strengthens Rare Disease Portfolio with Acquisition of Theravia
Details : Through the acquisition, Norgine will have six core products in its rare disease portfolio, which includes Siklos (hydroxyurea) is being indicated for the treatment of sickle cell anemia.
Product Name : Siklos
Product Type : Cytotoxic Drug
Upfront Cash : Undisclosed
April 15, 2025
Details:
Under the licensing agreement, Norgine will hold exclusive rights to commercialize Xolremdi (mavorixafor) in Europe, Australia, etc. It is being indicated for the treatment of WHIM syndrome.
Lead Product(s): Mavorixafor,Inapplicable
Therapeutic Area: Rare Diseases and Disorders Brand Name: Xolremdi
Study Phase: Approved FDFProduct Type: Miscellaneous
Recipient: X4 Pharmaceuticals
Deal Size: $260.5 million Upfront Cash: $29.1 million
Deal Type: Licensing Agreement January 13, 2025
Lead Product(s) : Mavorixafor,Inapplicable
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Recipient : X4 Pharmaceuticals
Deal Size : $260.5 million
Deal Type : Licensing Agreement
X4 Pharmaceuticals, Norgine Sign License for Mavorixafor in Europe, Australia
Details : Under the licensing agreement, Norgine will hold exclusive rights to commercialize Xolremdi (mavorixafor) in Europe, Australia, etc. It is being indicated for the treatment of WHIM syndrome.
Product Name : Xolremdi
Product Type : Miscellaneous
Upfront Cash : $29.1 million
January 13, 2025
Details:
Iwilfin (eflornithine) is a USFDA approved ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma.
Lead Product(s): Eflornithine Hydrochloride,Inapplicable
Therapeutic Area: Oncology Brand Name: Iwilfin
Study Phase: Approved FDFProduct Type: Amino Acid
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 06, 2025
Lead Product(s) : Eflornithine Hydrochloride,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Norgine Submits DFMO Marketing Application to EMA for Neuroblastoma
Details : Iwilfin (eflornithine) is a USFDA approved ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma.
Product Name : Iwilfin
Product Type : Amino Acid
Upfront Cash : Inapplicable
January 06, 2025
Details:
NRL001 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Fecal Incontinence.
Lead Product(s): NRL001,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 19, 2024
Lead Product(s) : NRL001,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Safety and Tolerability of the Twice Daily Intra-anal Application of NRL001 Cream for 14 Days
Details : NRL001 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Fecal Incontinence.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 19, 2024
Details:
NRL001 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Fecal Incontinence.
Lead Product(s): NRL001,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 19, 2024
Lead Product(s) : NRL001,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
The Safety and Dose Response to Single Anal Doses of NRL001
Details : NRL001 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Fecal Incontinence.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 19, 2024
Details:
NRL994 is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Colorectal Neoplasms.
Lead Product(s): NRL994,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 19, 2024
A Monocentric Study to Investigate a New Low Dose Oral Gut Cleansing Solution
Details : NRL994 is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Colorectal Neoplasms.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
September 19, 2024
Details:
Iwilfin (eflornithine) is a USFDA approved ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma.
Lead Product(s): Eflornithine Hydrochloride,Inapplicable
Therapeutic Area: Oncology Brand Name: Iwilfin
Study Phase: Approved FDFProduct Type: Amino Acid
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 15, 2024
Lead Product(s) : Eflornithine Hydrochloride,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Norgine Submits MAA for Eflornithine in High-Risk Neuroblastoma via Project Orbis
Details : Iwilfin (eflornithine) is a USFDA approved ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma.
Product Name : Iwilfin
Product Type : Amino Acid
Upfront Cash : Inapplicable
April 15, 2024
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