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Details:
The agreements aim to support Aspen for commercialization of Sandostatin LAR Depot (octreotide acetate), which is indicated for long-term treatment of acromegaly & severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Sandostatin LAR Depot
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Aspen Pharmacare Holdings
Deal Size: $99.9 million Upfront Cash: Undisclosed
Deal Type: Agreement December 04, 2023
Details:
CAM2029 is a ready-to-use octreotide for subcutaneous administration under development for treatment of acromegaly as well as gastroenteropancreatic neuroendocrine tumors (GEP-NET), and polycystic liver disease (PLD).
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: CAM2029
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 17, 2023
Details:
Debio 4126 (octreotide) is a synthetic octapeptide that mimics the pharmacology of endogenous somatostatin (SST). It demonstrates activity against growth hormone and glucagon, treating the disordered tissue growth and insulin regulation in patients with acromegaly.
Lead Product(s): Octreotide Acetate,Lanreotide Acetate
Therapeutic Area: Endocrinology Product Name: Debio 4126
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 12, 2023
Details:
Mycapssa® (oral octreotide) is approved by the FDA and the EC for long-term maintenance treatment in acromegaly patients who have responded to and tolerated injectable treatment with octreotide or lanreotide (i.e. somatostatin analogs (SSAs)).
Lead Product(s): Octreotide Acetate
Therapeutic Area: Oncology Product Name: Mycapssa
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Details:
Mycapssa (octreotide) is an oral prescription medicine used in the long-term maintenance treatment of acromegaly in people for whom initial treatment with octreotide or lanreotide has been effective and tolerated.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2022
Details:
Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2022
Details:
91% of patients on Mycapssa® (octreotide) maintained IGF-1 response (95% CI 44-53), throughout the RCT, compared to 100% on iSRLs (95% CI 34-37). Response was defined as the time-weighted average of IGF-1 <1.3 x upper limit of normal (ULN) during the 9-month RCT phase.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2022
Details:
Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2022
Details:
The study met its primary non-inferiority endpoint. 91% of patients on Mycapssa (octreotide) maintained insulin-like growth factor 1 (IGF-1) response (95% CI = 80%, 97%), throughout the RCT, compared to 100% on iSRLs (95% CI = 91%, 100%).
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2022
Details:
Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analog approved by the FDA.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Gastroenterology Product Name: Mycapssa
Highest Development Status: PreclinicalProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2022
Details:
The OPTIMAL study met the primary and all secondary endpoints which led to the US approval of Mycapssa (Octreotide), first oral somatostatin analog, for long-term maintenance treatment in acromegaly patients who tolerated treatment with injectable octreotide or lanreotide.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2022
Details:
The study achieved its objectives for Mycapssa® (octreotide capsules) and supports Phase 3 study in patients with carcinoid symptoms due to NET and results are consistent with prior PK study which was undertaken with these higher doses and compared to injectable SSA.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2022
Details:
CAM2029 is a ready-to-use, long-acting subcutaneous depot of octreotide used for the treatment of autosomal dominant polycystic liver disease. CAM2029 is developed for enhanced octreotide exposure and easy self-administration by patients using a prefilled pen injector.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Genetic Disease Product Name: CAM2029
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2021
Details:
RaniPill or RT-101 is being evaluated for acromegaly, and Rani expects to run trials for neuroendocrine tumor of the gastrointestinal tract as well as carcinoid syndrome.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Oncology Product Name: RT-101
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: BofA Securities
Deal Size: $73.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 26, 2021
Details:
The trial was designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules and patient-reported outcomes in patients treated with octreotide capsules, compared to patients treated with leading injectable somatostatin analogs.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2021
Details:
Combined business will have three approved commercial products, lomitapide (Lojuxta®/Juxtapid®), metreleptin (Myalept®/ Myalepta®), octreotide (MYCAPSSA®) and a robust clinical pipeline.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Amryt Pharma
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition May 05, 2021
Details:
Results from the ongoing OLE study show that the average IGF-1 levels of all patients treated with MYCAPSSA who completed the DPC period in the CHIASMA OPTIMAL trial and continued into the OLE were maintained within normal limits at the end of the 48-week OLE period.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2021
Details:
MYCAPSSA, the first and only oral somatostatin analog, approved by the U.S. FDA on June 26, 2020 for the long-term maintenance treatment of patients with acromegaly who have responded to and tolerated treatment with octreotide or lanreotide.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2020
Details:
Chiasma has obtained approval from the US Food and Drug Administration for MYCAPSSA® (octreotide) capsules. MYCAPSSA is the first and only oral somatostatin analog (SSA) approved by the FDA.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 02, 2020
Details:
Chiasma intends to use the net proceeds from the offering primarily for advancing the ongoing commercialization of MYCAPSSA® in the United States for the treatment of acromegaly and for other pipeline activities.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Jefferies
Deal Size: $70.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 01, 2020
Details:
The Phase I study successfully achieved both its primary and secondary endpoints, demonstrating the safety and tolerability of Octreotide-RP.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 30, 2020
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