X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
Details:
STS101 (dihydroergotamine nasal powder). STS101 is an investigational product which is being evaluated in phase 1 clinical trials for the acute treatment of migraine with or without aura in adults.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: STS101
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2024
Details:
PUR3100 is an orally inhaled formulation of dihydroergotamine (DHE) engineered with iSPERSE™ technology, which is investigated for the treatment of acute migraine.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: PUR3100
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2023
Details:
PUR3100 dry powder inhaler is under development as an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE™ for the acute treatment of migraine.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: PUR3100
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 11, 2023
Details:
STS101 (dihydroergotamine mesylate) constricts the pain-producing intracranial extracerebral blood vessels at the 5-HT1B receptors and inhibiting the trigeminal neurotransmission at the peripheral and central 5-HT1D receptors.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: STS101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2023
Details:
The acquisition will expand SNBL's pipeline by including STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: STS101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SNBL
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition April 16, 2023
Details:
PUR3100 (dihydroergotamine) is under development as an orally inhaled DHE engineered with iSPERSE™ for the acute treatment of migraine. The PUR3100 formulation is designed to disperse to the deep lung and rapidly enter the systemic circulation.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: PUR3100
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2023
Details:
PUR3100 (Dihydroergotamine) is under development as an orally inhaled DHE engineered with iSPERSE™ for the acute treatment of migraine. The PUR3100 formulation is designed to disperse to the deep lung and rapidly enter the systemic circulation.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: PUR3100
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2023
Details:
STS101 is designed to provide significant benefits versus existing acute treatments for migraine, including the combination of quick and convenient self-administration and other clinical advantages, that current DHE liquid nasal spray products and injectable dosage forms lack.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: STS101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2022
Details:
STS101 is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE), administered via Satsuma’s proprietary nasal delivery device.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: STS101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
STS101 is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE), administered via Satsuma’s proprietary nasal delivery device.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: STS101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
Subjects administered STS101 (dihydroergotamine mesylate) to treat their migraine attacks for as long as 18 months in a real-world setting, confirm the favorable safety and tolerability profile of STS101 observed to date in more than 1,600 clinical trial participants.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: STS101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2022
Details:
The co-primary endpoints of the SUMMIT trial, to be assessed at two hours after STS101 (Dihydroergotamine Mesylate) administration, are freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia or nausea).
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: STS101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 02, 2022
Details:
PUR3100, a novel pulmonary inhaled formulation of dihydroergotamine (DHE). PUR3100 is formulated using Pulmatrix's iSPERSE drug delivery technology and is being developed for the treatment of acute migraine.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: PUR3100
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 12, 2022
Details:
Trudhesa (Dihydroergotamine Mesylate), is a single use, drug-device combination product containing a vial of DHE, gently delivers DHE—a proven, well-established therapeutic6—quickly to the bloodstream through the vascular-rich upper nasal space.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: Trudhesa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2022
Details:
STS101 (dihydroergotamine mesylate) is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE), administered via Satsuma’s proprietary nasal delivery device.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: STS101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2022
Details:
This non-dilutive financing provides Impel with immediate and sufficient capital to support the continued successful launch and commercialization efforts for Trudhesa.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: Trudhesa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Oaktree Capital
Deal Size: $50.0 million Upfront Cash: $50.0 million
Deal Type: Financing March 17, 2022
Details:
STS101 is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE), administered via Satsuma’s proprietary nasal delivery device.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: STS101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2022
Details:
Using Impel’s proprietary POD® technology, Trudhesa delivers dihydroergotamine mesylate (DHE)—a proven, well-established therapeutic for acute migraine for adults—quickly to the bloodstream through the vascular-rich upper nasal space.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: Trudhesa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2022
Details:
In the trial, Trudhesa was generally well tolerated and exploratory efficacy findings showed it provided rapid, sustained, and consistent symptom relief.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: Trudhesa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2021
Details:
The SUMMIT Phase 3 efficacy trial of STS101 is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in approximately 1,400 subjects with migraine that is being conducted in the United States.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: STS101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2021
Details:
This strategic debt financing increases companies balance sheet strength and firmly positions us to execute upon the potential launch and commercialization of TRUDHESA™ for the treatment of patients with acute migraine.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: Trudhesa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Oxford Finance LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing July 07, 2021
Details:
The NDA submission for INP104 is supported by safety results from the pivotal Phase 3 STOP 301 study, in which over 5,650 migraine attacks were treated over 24 or 52 weeks.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: INP104
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
Within two hours of receiving their first dose of INP104, 38% of all patients reported freedom from migraine pain, 52% had freedom from their most bothersome migraine symptom (MBS) and 66.3% experienced pain relief.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: INP104
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2020
Details:
Topline data did not show statistically significant differences between either dosage strength of STS101 and placebo on co-primary endpoints of freedom from pain and most bothersome symptom at two hours post-administration.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: STS101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2020
Details:
The primary objective of the trial is to evaluate the long-term safety of STS101 as an as-needed acute treatment for migraine. Secondary outcome measures include efficacy evaluations,
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: STS101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
Details:
Impel Neuropharma presented additional findings from pivotal Phase 3 STOP 301 study, which further illustrates INP104’s potential to become an important new option for patients in the treatment of acute migraine.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
Exploratory Efficacy Data Reveal INP104 Resulted in Pain Relief in 66.3% of Patients and Pain Freedom in 38% of Patients at Two Hours After First Dose; Additionally, 16.3% of Patients Reported They Gained Initial Relief as Early as 15 Minutes.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2020
Details:
Satsuma Pharmaceuticals completed enrollment and randomization in its EMERGE pivotal Phase 3 efficacy trial of STS101 (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2020
Details:
Two abstracts and scientific presentations from its STS101 (dihydroergotamine (DHE) nasal powder) development program for the acute treatment of migraine were selected for presentation on the AAN 2020 Annual Meeting Science Highlights Virtual Platform.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020
Details:
The publication reports results from a Phase 1 study designed to investigate and compare the safety and PK of STS101, DHE liquid nasal spray (Migranal®), and intramuscular (IM) DHE injection in healthy subjects.
Lead Product(s): Dihydroergotamine Mesylate
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 28, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
