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Details:

BDSI intends to launch ELYXYB in the first quarter of 2022. Additionally, BDSI plans to conduct an ELYXYB pediatric study, which will have the potential to address the significant unmet needs of pediatric and adolescent patients suffering from migraine attacks.


Lead Product(s): Celecoxib

Therapeutic Area: Neurology Product Name: Elyxyb

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: BioDelivery Sciences

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition September 09, 2021

Details:

ELYXYB is an oral solution of celecoxib, formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption.


Lead Product(s): Celecoxib

Therapeutic Area: Neurology Product Name: Elyxyb

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: BioDelivery Sciences

Deal Size: $15.0 million Upfront Cash: $6.0 million

Deal Type: Acquisition August 04, 2021

Details:

Ethypharm has acquired the exclusive rights for the development, registration and commercialization in the top 5 European markets of a novel celecoxib formulation already approved in the US for the acute treatment of migraine. Celecoxib is developed by Dr Reddy's.


Lead Product(s): Celecoxib

Therapeutic Area: Neurology Product Name: Elyxyb

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Ethypharm

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition May 19, 2021

Details:

Lonza will develop, optimize, and qualify a method utilizing Neuron-Derived Exosomes, set to be integrated into the development program of PrimeC, a novel extended-release oral formulation of a unique fixed-dose combination of ciprofloxacin and celecoxib, by NeuroSense.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Lonza Group

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration April 09, 2024

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Details:

PrimeC is a novel extended-release oral formulation composed of a unique FDC of ciprofloxacin and celecoxib. It is under phase 2 clinical development for the treatment of amyotrophic lateral sclerosis (ALS).


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 21, 2024

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Details:

IMC-2 (combination of valacyclovir and celecoxib) is being evaluated in phase 2 clinical trials as a potential treatment for managing the fatigue, sleep, attention, pain, autonomic function and anxiety associated with Long COVID.


Lead Product(s): Valacyclovir,Celecoxib

Therapeutic Area: Infections and Infectious Diseases Product Name: IMC-2

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 22, 2024

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Details:

IMC-2 (combination of valacyclovir + celecoxib) is being evaluated in phase 2 clinical trials as a treatment for the fatigue, orthostatic intolerance and other symptoms associated with LC illness, also known as post-acute sequelae of SARS-CoV-2 infection (PASC) or Long Covid.


Lead Product(s): Valacyclovir,Celecoxib

Therapeutic Area: Infections and Infectious Diseases Product Name: IMC-2

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 02, 2024

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Details:

Elyxyb (celecoxib) is a nonsteroidal anti-inflammatory drug that acts as a cyclooxygenase-2 inhibitor. It is indicated for the acute treatment of migraine with or without aura in adults.


Lead Product(s): Celecoxib

Therapeutic Area: Neurology Product Name: Elyxyb

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 26, 2023

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Details:

PrimeC is a novel extended-release oral formulation composed of a unique FDC of ciprofloxacin and celecoxib. It is under phase 2 clinical development for the treatment of amyotrophic lateral sclerosis (ALS).


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 14, 2023

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Details:

Elyxyb (celecoxib) is a nonsteroidal anti-inflammatory drug with analgesic, anti-inflammatory, and antipyretic properties. Celecoxib inhibits prostaglandin synthesis, primarily via inhibition of COX-2. It is being developed for migrane pain.


Lead Product(s): Celecoxib

Therapeutic Area: Neurology Product Name: Elyxyb

Highest Development Status: Phase IVProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 22, 2023

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Details:

PrimeC (ciprofloxacin and celecoxib) is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 13, 2023

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Details:

PrimeC (ciprofloxacin and celecoxib) is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 06, 2023

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Details:

NeuroSense terminated the offering as the company is fully funded beyond clinical phase 2b ALS results of PrimeC, a unique formulation of a fixed-dose combination drug comprising ciprofloxacin and celecoxib, for amyotrophic lateral sclerosis.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Public Offering October 02, 2023

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Details:

The Company has initiated the 10-day termination process under the Sales Agreement and is focusing its attention on short-to-medium term operational priorities, including assessment of IMC-2 (fixed combination of valacyclovir and celecoxib) in Long-COVID.


Lead Product(s): Valacyclovir,Celecoxib

Therapeutic Area: Infections and Infectious Diseases Product Name: IMC-2

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: JonesTrading Institutional Services

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Termination September 18, 2023

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Details:

Ampligen® (rintatolimod) is an immuno-modulator with broad spectrum activity and is being evaluated in combination with Paclitaxel in Phase 1 Study for the treatment of people with early-stage triple negative breast cancer.


Lead Product(s): Rintatolimod,Celecoxib,Cyclophosphamide

Therapeutic Area: Oncology Product Name: Ampligen

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 11, 2023

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Details:

F14 (celecoxib) is a sustained-release formulation of the non-steroidal anti-inflammatory drug (NSAID), celecoxib, administered into the intra-articular space at the end of TKR surgery.


Lead Product(s): Celecoxib,Bupivacaine Hydrochloride,Paracetamol

Therapeutic Area: Neurology Product Name: F14 (mdc-CWM)

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 30, 2023

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Details:

IMC-1 (famciclovir) is a fixed dose combination of famciclovir and celecoxib designed to synergistically suppress herpes virus replication, with the end goal of reducing virally promoted disease symptoms. It is being investegated for the treatment of fibromyalgia.


Lead Product(s): Famciclovir,Celecoxib

Therapeutic Area: Musculoskeletal Product Name: IMC-1

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 09, 2023

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Details:

IMC-2 is a combination of valacyclovir, which inhibits viral DNA polymerase and celecoxib, which is COX-2 inhibitor, as a potential treatment for managing fatigue, sleep, attention, pain, autonomic function and anxiety associated with post-acute sequelae of COVID-19.


Lead Product(s): Valacyclovir,Celecoxib

Therapeutic Area: Infections and Infectious Diseases Product Name: IMC-2

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 17, 2023

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Details:

The net proceeds will advance the clinical development of PrimeC (ciprofloxacin) for amyotrophic lateral sclerosis and for the clinical development potential investigational new drug applications for Alzheimer's disease, for Parkinson's disease and for other indications.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Alliance Global Partners

Deal Size: $4.5 million Upfront Cash: Undisclosed

Deal Type: Public Offering June 22, 2023

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Details:

Under the terms of the agreement, Biogen will evaluate the impact of PrimeC (ciprofloxacin) and celecoxib on neurofilament levels in the plasma of participants in PARADIGM, NeuroSense’s Phase 2b clinical trial for the treatment of amyotrophic lateral sclerosis.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Biogen

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration June 14, 2023

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Details:

PrimeC (ciprofloxacin and celecoxib) is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 15, 2023

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Details:

StabiliC is a combination consisting of ciprofloxacin and celecoxib which is currently being investigated in preclinical studies for the treament of parkinson's disease.


Lead Product(s): Celecoxib,Ciprofloxacin

Therapeutic Area: Neurology Product Name: StabiliC

Highest Development Status: PreclinicalProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 03, 2023

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Details:

IMC-1 (famciclovir) is a fixed dose combination of famciclovir and celecoxib designed to synergistically suppress herpes virus replication, with the end goal of reducing virally promoted disease symptoms. It is being investegated for the treatment of fibromyalgia.


Lead Product(s): Famciclovir,Celecoxib

Therapeutic Area: Musculoskeletal Product Name: IMC-1

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 24, 2023

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Details:

NeuroSense & Massachusetts General Hospital will explore the neurotherapeutic effects of PrimeC, utilizing a novel in vitro model generated from post-mortem ALS brain tissue. PrimeC is a novel unique fixed-dose combination of ciprofloxacin and celecoxib.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Massachusetts General Hospital

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration March 27, 2023

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Details:

Elyxyb (celecoxib) is a nonsteroidal anti-inflammatory drug with analgesic, anti-inflammatory, and antipyretic properties. Celecoxib inhibits prostaglandin synthesis, primarily via inhibition of COX-2. It is being developed for migrane pain.


Lead Product(s): Celecoxib

Therapeutic Area: Neurology Product Name: Elyxyb

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 27, 2023

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Details:

IMC-2 is a combination of valacyclovir, which inhibits viral DNA polymerase and celecoxib, which is COX-2 inhibitor, as a potential treatment for managing fatigue, sleep, attention, pain, autonomic function and anxiety associated with post-acute sequelae of COVID-19.


Lead Product(s): Valacyclovir,Celecoxib

Therapeutic Area: Infections and Infectious Diseases Product Name: IMC-2

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 13, 2023

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  • Deals

Details:

Through the acquisition, ELYXYB has the potential to further expand Scilex’s non-opioid portfolio in broader acute pain indications. ELYXYB is an oral solution of celecoxib, formulated using a self-micro emulsifying drug delivery system.


Lead Product(s): Celecoxib

Therapeutic Area: Neurology Product Name: Elyxyb

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Scilex Holding Company

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition February 12, 2023

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Details:

PrimeC (ciprofloxacin and celecoxib) is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 08, 2023

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Details:

IMC-1 (Famciclovir) is a fixed dose combination of famciclovir and celecoxib designed to synergistically suppress herpes virus replication, with the end goal of reducing virally promoted disease symptoms. IMC-1 has been granted fast track designation by the FDA.


Lead Product(s): Famciclovir,Celecoxib

Therapeutic Area: Musculoskeletal Product Name: IMC-1

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 05, 2023

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Details:

PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 15, 2022

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Details:

PrimeC is a novel formulation composed of unique doses of two FDA-approved drugs, Ciprofloxacin and Celecoxib, which aim to synergistically inhibit the progression of ALS by aiming to regulate microRNA synthesis, reduce neuroinflammation, and influence iron accumulation.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 27, 2022

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Details:

PrimeC's (ciprofloxacin) upgraded formulation, which is a unique extended-release tablet, designed to maximize the synergism between the compounds, is now being evaluated in a Phase IIb clinical trial, PARADIGM, for the treatment of ALS.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 12, 2022

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Details:

The Company intends to use the net proceeds from the offering primarily to further advance the clinical development of IMC-1 (famciclovir) and for working capital and general corporate purposes.


Lead Product(s): Famciclovir,Celecoxib

Therapeutic Area: Musculoskeletal Product Name: IMC-1

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: ThinkEquity

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Public Offering September 22, 2022

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Details:

PrimeC (ciprofloxacin) is a novel extended-release oral formulation composed of a unique fixed-dose combination of the two drugs, which are U.S. Food and Drug Administration (FDA)-approved. NeuroSense is currently evaluating PrimeC in PARADIGM, a Phase IIb clinical trial.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 20, 2022

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Details:

The Company intends to use the net proceeds from the offering primarily to further advance the clinical development of IMC-1 (famciclovir) and for working capital and general corporate purposes.


Lead Product(s): Famciclovir,Celecoxib

Therapeutic Area: Musculoskeletal Product Name: IMC-1

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: ThinkEquity

Deal Size: $10.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering September 19, 2022

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Details:

IMC-1 (famciclovir) was well-tolerated overall, with only 4.6% of patients dropping out due to adverse events, as compared with 8.1% of placebo treated patients. No adverse event category in the IMC-1 group exceeded a 4% rate with the exception of COVID-19 infection.


Lead Product(s): Famciclovir,Celecoxib

Therapeutic Area: Musculoskeletal Product Name: IMC-1

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 19, 2022

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Details:

Phase IIa clinical study of PrimeC's (ciprofloxacin) successfully met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 19, 2022

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Details:

ELYXYB™ (celecoxib) oral solution is prescription nonsteroidal anti-inflammatory drug (NSAID) used for the acute treatment of migraine with or without aura in adult.


Lead Product(s): Celecoxib

Therapeutic Area: Neurology Product Name: Elyxyb

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 30, 2022

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Ampligen (rintatolimod) is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system.


Lead Product(s): Rintatolimod,Interferon Alfa-2B,Celecoxib

Therapeutic Area: Oncology Product Name: Ampligen

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Roswell Park Comprehensive Cancer Center

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 30, 2022

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Details:

IMC-2 (valacyclovir + celecoxib), to treat the symptoms associated with Long-COVID, including fatigue, pain, sleep disruption, anxiety, depression and cognitive function and overall health improvement.


Lead Product(s): Valacyclovir,Celecoxib

Therapeutic Area: Infections and Infectious Diseases Product Name: IMC-2

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 August 15, 2022

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Details:

Ampligen® (rintatolimod) has demonstrated promising activity as a potential maintenance therapy after systemic chemotherapy in patients with metastatic and locally advanced pancreatic cancer (LAPC).


Lead Product(s): Rintatolimod,Interferon Alfa-2B,Celecoxib

Therapeutic Area: Oncology Product Name: Ampligen

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 20, 2022

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Details:

The primary efficacy endpoint met and studied was summed pain intensity difference from 0 to 48 hours (SPID0-48). SEGLENTIS (celecoxib) had a significantly greater effect on SPID0-48 (least-squares mean: −139.1 than tramadol, celecoxib or placebo.


Lead Product(s): Celecoxib,Tramadol Hydrochloride

Therapeutic Area: Neurology Product Name: Seglentis

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 19, 2022

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Details:

Phase IIa clinical study which successfully met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC (ciprofloxacin) biological activity.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 22, 2022

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Details:

PrimeC is a novel formulation composed of unique doses of two FDA-approved drugs, Ciprofloxacin and Celecoxib, which aim to synergistically inhibit the progression of ALS.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 22, 2022

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Details:

Phase IIa study for PrimeC (Ciprofloxacin), successfully met safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biomarkers.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2022

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Details:

Analysis of gastric mucosa biopsies revealed a significant positive association between actively replicating gastric HSV-1 and multiple functional gastrointestinal disorders, with and without concomitant FM.


Lead Product(s): Famciclovir,Celecoxib

Therapeutic Area: Musculoskeletal Product Name: IMC-1

Highest Development Status: PreclinicalProduct Type: Small molecule

Partner/Sponsor/Collaborator: University of Alabama

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2022

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PrimeC (ciprofloxacin), is a novel formulation consisting of unique doses of two FDA-approved drugs designed to work synergistically on several targets including regulating microRNA synthesis, affecting iron accumulation, and reducing neuroinflammation.


Lead Product(s): Ciprofloxacin,Celecoxib

Therapeutic Area: Neurology Product Name: PrimeC

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 23, 2022

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IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress herpes virus activation and replication.


Lead Product(s): Famciclovir,Celecoxib

Therapeutic Area: Musculoskeletal Product Name: IMC-1

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 28, 2022

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The data, from a small number of subjects, is extremely impressive for four out of six Ampligen plus pembrolizumab patients; three demonstrated disease stabilization and one showed a significant and dramatic rapid destruction of the tumor and metastasis.


Lead Product(s): Rintatolimod,Celecoxib,Pembrolizumab

Therapeutic Area: Oncology Product Name: Ampligen

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Roswell Park Comprehensive Cancer Center

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 11, 2022

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Primary endpoint of the study was met for Ampligen (rintatolimod), selective TLR3 ligand, evidenced by increased CD8a expression post-treatment (p=0.046), as a component of treatment for colorectal cancer metastatic to the liver.


Lead Product(s): Rintatolimod,Celecoxib,Recombinant Interferon Alfa-2b

Therapeutic Area: Oncology Product Name: Ampligen

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Roswell Park Comprehensive Cancer Center

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 11, 2022

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