Endocrinology | Approved Drugs | Pipeline Prospector

Lannett Company, Inc.

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United States

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Chinaplas 2020

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Lannett and Cediprof Announce Exclusive Distribution Agreement for An Approved Levothyroxine

Lead Product(s): Levothyroxine Sodium

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Cediprof

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement July 16, 2020

Details:

The companies have entered into an interim exclusive supply and distribution agreement for Cediprof's FDA approved Levothyroxine Sodium Tablets USP.

Chiasma

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Chinaplas 2020

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Camargo Client Chiasma Receives FDA Approval for Novel Somatostatin Analog for Long-Term Maintenance Treatment of Acromegaly

Lead Product(s): Octreotide Acetate

Therapeutic Area: Endocrinology Product Name: Mycapssa

Highest Development Status: Approved Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 02, 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.

Chiasma

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Chinaplas 2020

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Chiasma Announces Pricing of a Public Offering of $70 Million of Common Stock and Pre-Funded Warrants

Lead Product(s): Octreotide Acetate

Therapeutic Area: Endocrinology Product Name: Mycapssa

Highest Development Status: Approved Product Type: Peptide

Partner/Sponsor/Collaborator: Jefferies

Deal Size: $70.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering July 01, 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.

Aeterna Zentaris

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Chinaplas 2020

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Aeterna Zentaris Announces Pricing of $12 Million Public Offering

Lead Product(s): Macimorelin

Therapeutic Area: Endocrinology Product Name: Macrilen

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

Deal Size: $12.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering July 01, 2020

Details:

The Company intends to use the net proceeds of this offering for general corporate purposes, which includes funding of a pediatric clinical trial in the E.U. and U.S. for Macrilen, the investigation of further therapeutic uses of macimorelin.

Otsuka Pharmaceutical

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JAPAN Japan

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Chinaplas 2020

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Samsca®Approved in Japan for Additional Indication of Hyponatremia Due to Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

Lead Product(s): Tolvaptan

Therapeutic Area: Endocrinology Product Name: Samsca

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 29, 2020

Details:

Oral vasopressin V2-receptor antagonists Samsca® Tablets, Samsca® OD Tablets and SAMSCA® Granules 1% have received regulatory approval in Japan for the indication of hyponatraemia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH) in adults.

Novo Nordisk

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DENMARK Denmark

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Chinaplas 2020

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Rybelsus® approved in Japan for the treatment of type 2 diabetes

Lead Product(s): Semaglutide

Therapeutic Area: Endocrinology Product Name: Rybelsus

Highest Development Status: Approved Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 29, 2020

Details:

The approval of Rybelsus® in Japan is based on results from the PIONEER clinical trial programme, which involved more than 9,500 adults with type 2 diabetes, including approximately 1,300 adults from Japan.

Recordati Rare Diseases

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Chinaplas 2020

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Recordati Rare Diseases: Isturisa® (osilodrostat) Phase III LINC-4 Trial Meets Its Primary Endpoint in Cushing’s Disease

Lead Product(s): Osilodrostat

Therapeutic Area: Endocrinology Product Name: Isturisa

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 17, 2020

Details:

ISTURISA® (osilodrostat) demonstrates significant and sustained benefit over placebo at normalizing mean urinary free cortisol (mUFC) levels in patients with Cushing’s disease.

Merck & Co. Inc.

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Chinaplas 2020

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Merck and Pfizer’s Steglatrotm Meets Primary Endpoint in VERTIS CV Trial for Type 2 Diabetes and Atherosclerotic Cardiovascular Disease

Lead Product(s): Ertugliflozin

Therapeutic Area: Endocrinology Product Name: Steglatro

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 16, 2020

Details:

Phase 3 VERTIS CV cardiovascular outcomes trial evaluated STEGLATRO (ertugliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, vs placebo, added to background standard of care treatment, in patients with type 2 diabetes and atherosclerotic CV disease.

Mankind Pharma

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INDIA India

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Chinaplas 2020

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ManKind Presents Positive Original Analyses of Afrezza® Clinical Data at American Diabetes Association (ADA) 80th Scientific Sessions

Lead Product(s): Insulin

Therapeutic Area: Endocrinology Product Name: Afrezza

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 15, 2020

Details:

Company announced that new data from clinical studies of Afrezza® demostrating safe and effective dosing, its association with weight loss in patients with type 2 diabetes, and an evaluation of a comprehensive two year safety study showing that significant changes in FEV1.

Takeda Pharmaceutical

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JAPAN Japan

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Takeda to Divest Select APAC Assets to Celltrion for $278M

Lead Product(s): Alogliptin

Therapeutic Area: Endocrinology Product Name: Nesina

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Celltrion

Deal Size: $278.0 million Upfront Cash: $266.0 million

Deal Type: Divestment June 11, 2020

Details:

The portfolio to be divested to Celltrion includes a variety of OTC products and pharmaceutical products such as Nesina® and Edarbi® and Products in a variety of indications.

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Approved

Product Type

Companies

Lannett Company, Inc.

Lannett and Cediprof Announce Exclusive Distribution Agreement for An Approved Levothyroxine

Chiasma

Camargo Client Chiasma Receives FDA Approval for Novel Somatostatin Analog for Long-Term Maintenance Treatment of Acromegaly

Chiasma

Chiasma Announces Pricing of a Public Offering of $70 Million of Common Stock and Pre-Funded Warrants

Aeterna Zentaris

Aeterna Zentaris Announces Pricing of $12 Million Public Offering

Otsuka Pharmaceutical

Samsca®Approved in Japan for Additional Indication of Hyponatremia Due to Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

Novo Nordisk

Rybelsus® approved in Japan for the treatment of type 2 diabetes

Recordati Rare Diseases

Recordati Rare Diseases: Isturisa® (osilodrostat) Phase III LINC-4 Trial Meets Its Primary Endpoint in Cushing’s Disease

Merck & Co. Inc.

Merck and Pfizer’s Steglatrotm Meets Primary Endpoint in VERTIS CV Trial for Type 2 Diabetes and Atherosclerotic Cardiovascular Disease

Mankind Pharma

ManKind Presents Positive Original Analyses of Afrezza® Clinical Data at American Diabetes Association (ADA) 80th Scientific Sessions

Takeda Pharmaceutical

Takeda to Divest Select APAC Assets to Celltrion for $278M