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  • TABLET;ORAL - 10MG
  • TABLET;ORAL - 2.5MG
  • TABLET;ORAL - 20MG
  • TABLET;ORAL - 5MG
  • TABLET;ORAL - 20MG

Details:

Cialis is a tablet having Tadalafil to treat erectile dysfunction, and symptoms of benign prostatic hyperplasia, and both ED and the signs and symptoms of BPH. Cialis is the only PDE-5 inhibitor treatment that offers men a choice fot treatment of erectile dysfunction.


Lead Product(s): Tadalafil

Therapeutic Area: Psychiatry/Psychology Product Name: Cialis

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 30, 2022

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Details:

Finasteride and tadalafil combination is used to treat men with benign prostatic hyperplasia (BPH). Tadalafil is a PDE5 inhibitor and finasteride blocks the action of 5-alpha-reductase which will increase testosterone levels in the body, which decreases prostate size.


Lead Product(s): Finasteride,Tadalafil

Therapeutic Area: Urology Product Name: Finasteride/Tadalafil-Generic

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 26, 2021

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Details:

CDSCO has approved Silodosin (selective alpha1A-adrenergic receptor antagonist) + Tadalafil (PDE5 inhibitor), a fixed dose combination for the treatment of benign prostatic hyperplasia.


Lead Product(s): Silodosin,Tadalafil

Therapeutic Area: Urology Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 07, 2023

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Details:

Emifarma will be responsible for the initial stages of development and testing of the Company’s Mango ED products, including Mango ED, a combination of Tadalafil, Oxytocin, and L-Arginine, intended for the Mexican and Latin American markets.


Lead Product(s): Tadalafil,Oxytocin,L-Arginine

Therapeutic Area: Psychiatry/Psychology Product Name: Mango ED

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Mangoceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement April 12, 2024

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Details:

Opsynvi is a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor. It is approved for the chronic treatment of adults with pulmonary arterial hypertension.


Lead Product(s): Macitentan,Tadalafil

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Opsynvi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 22, 2024

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Details:

The net proceeds will be utilized for the commercialisation of Exordia (tadalafil), it comprises one of the three main PDE5 inhibitors. It is being evaluated in the treatment of erectile dysfunction.


Lead Product(s): Tadalafil

Therapeutic Area: Psychiatry/Psychology Product Name: Exordia

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Digital Offering, LLC

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Public Offering February 20, 2024

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Details:

Through the acquisition, Zuellig will have the access for Cialis (tadalafil), used to treat erectile dysfunction, and Alimta (pemetrexed), for the treatment of pleural mesothelioma and non-small cell lung cancer, from Eli Lilly.


Lead Product(s): Tadalafil

Therapeutic Area: Psychiatry/Psychology Product Name: Cialis

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Zuellig Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition February 06, 2024

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Details:

The combined company will focus on the R&D and commercialization of proprietary science and technologies for therapeutics, including Entadfi, a once-daily, oral treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a PDE5 inhibitor.


Lead Product(s): Finasteride,Tadalafil

Therapeutic Area: Urology Product Name: Entadfi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Blue Water Vaccines

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition December 18, 2023

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Details:

The Company intends to use the net proceeds to finance the marketing and operational expenses associated with the planned marketing of its Mango ED, a combination of Tadalafil, Oxytocin, and L-Arginine that have been traditionally used to treat sexual dysfunction.


Lead Product(s): Tadalafil,Oxytocin,L-Arginine

Therapeutic Area: Psychiatry/Psychology Product Name: Mango ED

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Boustead Securities

Deal Size: $1.2 million Upfront Cash: Undisclosed

Deal Type: Public Offering December 15, 2023

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Details:

DCGI has approved Tamsulosin (selective alpha1A-adrenergic receptor antagonist) + Tadalafil, a fixed dose combination within a hard gelatin capsule for the treatment of erectile dysfunction & benign prostatic hyperplasia.


Lead Product(s): Tamsulosin,Tadalafil

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 15, 2023

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Details:

Sweet Remedy (tadalafil) gummy is a PDE5 inhibitor, small molecule drug. It is being evaluated in phase 1 clinical trials for the treatment of patients with erectile dysfunction.


Lead Product(s): Tadalafil

Therapeutic Area: Psychiatry/Psychology Product Name: Sweet Remedy

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 October 24, 2023

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Details:

DKF-313 is a combination of dutasteride (5α-reductase inhibitor) and tadalafil (PDE5 inhibitor). It is being evaluated in phase 3 clinical trials for the treatment of benign prostatic hyperplasia.


Lead Product(s): Dutasteride,Tadalafil

Therapeutic Area: Urology Product Name: DKF-313

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 26, 2023

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Details:

The partnership aims bring its flagship product, Mango, a combination of Tadalafil, Oxytocin, and L-Arginine that have been traditionally used to treat sexual dysfunction, to New York.


Lead Product(s): Tadalafil,Oxytocin,L-Arginine

Therapeutic Area: Psychiatry/Psychology Product Name: Mango

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Greater NY Chamber of Commerce

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership August 09, 2023

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Details:

ACT-064992D (macitentan/tadalafil ) Tablet act Endothelin A receptor antagonists, macitentan, and the PDE5 inhibitor, tadalafil, used for long-term treatment of PAH in adult patients of WHO Functional Class (FC) II to III.


Lead Product(s): Macitentan,Tadalafil

Therapeutic Area: Cardiology/Vascular Diseases Product Name: ACT-064992D

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 26, 2023

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Details:

Under the collaboration, Blue Water Biotech and IQVIA will market Blue Water’s commercial portfolio including, Entadfi, an FDA-approved, once daily pill that combines finasteride and tadalafil for benign prostatic hyperplasia and Zontivity (vorapaxar).


Lead Product(s): Finasteride,Tadalafil

Therapeutic Area: Urology Product Name: Entadfi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: IQVIA

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration June 21, 2023

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Details:

Profervia is a novel form of cilnidipine, a fourth-generation calcium channel blocker (CCB), which is investigated for the treatment of Raynaud's Phenomenon in Systemic Sclerosis (SSc).


Lead Product(s): Cilnidipine,Tadalafil

Therapeutic Area: Immunology Product Name: Profervia

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 21, 2023

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Details:

Tadalafil Tablets phosphodiesterase inhibitor indicated for the treatment of pulmonary arterial hypertension and improve exercise capacity in men and women.


Lead Product(s): Tadalafil

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Adcirca-Generic

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 07, 2023

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Details:

The investigational single tablet combination therapy of ACT-064992D (macitentan) Endothelin A receptor 10mg and tadalafil PDE5 inhibitor 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension.


Lead Product(s): Macitentan,Tadalafil

Therapeutic Area: Cardiology/Vascular Diseases Product Name: ACT-064992D

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 30, 2023

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Details:

Cialis-generic (tadalafil) is an orally avilable PDE5 inhibitor USFDA approved drug candidate. It is approved in Mexico & Chile for the treatment of erectile dysfunction.


Lead Product(s): Tadalafil

Therapeutic Area: Psychiatry/Psychology Product Name: Cialis-Generic

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 26, 2023

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Details:

The acquisition transforms the Company into a broader pharmaceutical company spanning multiple sectors by including ENTADFI (finasteride), an oral, once daily treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a PDE5 inhibitor.


Lead Product(s): Finasteride,Tadalafil

Therapeutic Area: Urology Product Name: Entadfi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Blue Water Vaccines

Deal Size: $100.0 million Upfront Cash: $20.0 million

Deal Type: Agreement April 20, 2023

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Details:

A combination of opsumit (macitentan) and tadalafil is being investigated to improve pulmonary hemodynamics, where opsumit is an ERA antagonist and tadalafil relaxes blood vessels and lowers the blood pressure in lungs, to allow blood to flow more easily.


Lead Product(s): Macitentan,Tadalafil

Therapeutic Area: Cardiology/Vascular Diseases Product Name: ACT-064992D

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 06, 2023

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  • Development Update

Details:

Cialis (tadalafil) is a selective phosphodiesterase-5 (PDE5) inhibitor that produces several downstream effects with the most common therapeutic effect being smooth muscle relaxation in the penis, allowing the corpus cavernosum to fill with blood to produce an erection.


Lead Product(s): Tadalafil

Therapeutic Area: Psychiatry/Psychology Product Name: Cialis

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 07, 2023

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Details:

Tadliq is the first and only FDA-approved liquid oral suspension of tadalafil for adult patients with difficulty swallowing. Tadliq is indicated for the treatment of pulmonary arterial hypertension and ensures consistent dosing.


Lead Product(s): Tadalafil

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Tadliq

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 24, 2022

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Details:

In the USA all clinically proven oral ED therapies are prescription-only and therefore FM71/MED3000 has the potential to be a significant innovation with its key differentiator of a rapid speed of onset and by creating a major new OTC category for ED treatment.


Lead Product(s): Tadalafil

Therapeutic Area: Psychiatry/Psychology Product Name: MED3000

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 31, 2022

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Details:

Cialis® (tadalafil), is indicated for the treatment of erectile dysfunction and benign prostatic hyperplasia, and Cialis® is positioned as the top 2 brand product for erectile dysfunction treatment with high brand loyalty.


Lead Product(s): Tadalafil

Therapeutic Area: Psychiatry/Psychology Product Name: Cialis

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Lotus Pharmaceutical Industries

Deal Size: $57.5 million Upfront Cash: Undisclosed

Deal Type: Acquisition March 22, 2022

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Details:

ENTADFI (finasteride and tadalafil) capsules for oral use, a new treatment for urinary tract symptoms caused by an enlarged prostate called benign prostatic hyperplasia.


Lead Product(s): Finasteride,Tadalafil

Therapeutic Area: Urology Product Name: Entadfi

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 13, 2021

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Details:

Health Canada approved OPSYNVI® (macitentan 10mg and tadalafil 40mg) for long-term treatment of pulmonary arterial hypertension. Macitentan is antagonist/blocker of endothelin receptors on blood vessels and smooth muscle, and tadalafil is a selective inhibitor of PDE5.


Lead Product(s): Macitentan,Tadalafil

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Opsynvi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 15, 2021

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Details:

Partnership will support the development and commercialization of Tadalafil oral films for the treatment of erectile dysfunction (“ED”) and benign prostatic hyperplasia (BPH).


Lead Product(s): Tadalafil

Therapeutic Area: Psychiatry/Psychology Product Name: AQST-119

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: IntelGenx

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership September 29, 2021

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Details:

Cialis®, and the generic equivalent Tadalafil, is in a class of medications called phosphodiesterase (PDE) inhibitors. Tadalafil is used to treat erectile dysfunction and the symptoms of benign prostatic hyperplasia (BPH; an enlarged prostate).


Lead Product(s): Tadalafil

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: ECI Pharmaceuticals LLC

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement May 10, 2021

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Details:

Glenmark Pharmaceuticals Ltd has received final approval from the United States Food and Drug Administration (USFDA) for Tadalafil tablets USP in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, the company said in a regulatory filing.


Lead Product(s): Tadalafil

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

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 31, 2020

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Details:

Tadalafil Tablets is a phosphodiesterase inhibitor that indicated for the treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia.


Lead Product(s): Tadalafil

Therapeutic Area: Psychiatry/Psychology Product Name: Cialis-Generic

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 31, 2020

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Details:

While the primary endpoint was not met, exploratory analysis suggests a signal of reduced risk of disease progression of initial triple oral combination therapy vs initial double oral therapy for Pulmonary Arterial Hypertension (PAH) patients .


Lead Product(s): Selexipag,Macitentan,Tadalafil

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Uptravi

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 29, 2020

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