Overview
Selexipag was approved by the United States FDA on December 22, 2015 for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce risk of hospitalization. PAH is a relatively rare disease with usually a poor prognosis requiring more treatment options to prolong long-term outcomes. Marketed by Actelion Pharmaceuticals under brand name Uptravi, selexipag and its active metabolite, ACT-333679 (MRE-269), act as agonists of the prostacyclin receptor to increase vasodilation in the pulmonary circulation and decrease elevated pressure in the blood vessels supplying blood to the lungs.
Indication
Selexipag is indicated for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce risk of hospitalization.
Associated Conditions
- Pulmonary arterial hypertension WHO functional class I
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/04/24 | Phase 4 | Recruiting | |||
2022/01/05 | Phase 3 | Recruiting | Actelion | ||
2021/06/04 | N/A | AVAILABLE | Actelion | ||
2020/10/19 | Phase 2 | UNKNOWN | |||
2020/09/28 | Phase 3 | Completed | Actelion | ||
2020/06/17 | Phase 4 | Terminated | Actelion | ||
2020/02/12 | Phase 1 | Completed | Actelion | ||
2019/11/25 | Phase 3 | Active, not recruiting | Actelion | ||
2019/05/08 | Phase 2 | Terminated | Actelion | ||
2018/09/28 | Phase 3 | Terminated | Actelion |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Actelion Pharmaceuticals US, Inc. | 66215-614 | ORAL | 1400 ug in 1 1 | 4/19/2023 | |
| Actelion Pharmaceuticals US, Inc. | 66215-602 | ORAL | 200 ug in 1 1 | 4/19/2023 | |
| Actelion Pharmaceuticals US, Inc. | 66215-606 | ORAL | 600 ug in 1 1 | 4/19/2023 | |
| Actelion Pharmaceuticals US, Inc. | 66215-608 | ORAL | 800 ug in 1 1 | 4/19/2023 | |
| Actelion Pharmaceuticals US, Inc. | 66215-612 | ORAL | 1200 ug in 1 1 | 4/19/2023 | |
| Actelion Pharmaceuticals US, Inc. | 66215-616 | ORAL | 1600 ug in 1 1 | 4/19/2023 | |
| Actelion Pharmaceuticals US, Inc. | 66215-718 | INTRAVENOUS | 1800 ug in 10 mL | 4/19/2023 | |
| Actelion Pharmaceuticals US, Inc. | 66215-604 | ORAL | 400 ug in 1 1 | 4/19/2023 | |
| Actelion Pharmaceuticals US, Inc. | 66215-610 | ORAL | 1000 ug in 1 1 | 4/19/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/12/2016 | ||
Authorised | 5/12/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| UPTRAVI FILM-COATED TABLETS 1600MCG | SIN15290P | TABLET, FILM COATED | 1.6 mg | 7/6/2017 | |
| UPTRAVI FILM-COATED TABLETS 1200MCG | SIN15288P | TABLET, FILM COATED | 1.2 mg | 7/6/2017 | |
| UPTRAVI FILM-COATED TABLETS 1400MCG | SIN15289P | TABLET, FILM COATED | 1.4 mg | 7/6/2017 | |
| UPTRAVI FILM-COATED TABLETS 1000MCG | SIN15287P | TABLET, FILM COATED | 1.0 mg | 7/6/2017 | |
| UPTRAVI FILM-COATED TABLETS 400MCG | SIN15284P | TABLET, FILM COATED | 0.4 mg | 7/6/2017 | |
| UPTRAVI FILM-COATED TABLETS 600MCG | SIN15285P | TABLET, FILM COATED | 0.6 mg | 7/6/2017 | |
| UPTRAVI FILM-COATED TABLET 200MCG | SIN15283P | TABLET, FILM COATED | 0.2 mg | 7/6/2017 | |
| UPTRAVI FILM-COATED TABLETS 800MCG | SIN15286P | TABLET, FILM COATED | 0.8 mg | 7/6/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| UPTRAVI TABLETS 600MCG | N/A | N/A | N/A | 2/6/2018 | |
| UPTRAVI TABLETS 1600MCG | N/A | N/A | N/A | 2/6/2018 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| UPTRAVI selexipag 600 microgram film-coated tablet blister pack | 234159 | Medicine | A | 3/24/2016 | |
| UPTRAVI selexipag 1000 microgram film-coated tablet blister pack | 234162 | Medicine | A | 3/24/2016 | |
| UPTRAVI selexipag 1200 microgram film-coated tablet blister pack | 234163 | Medicine | A | 3/24/2016 | |
| UPTRAVI selexipag 800 microgram film-coated tablet blister pack | 234166 | Medicine | A | 3/24/2016 | |
| UPTRAVI selexipag 200 microgram film-coated tablet blister pack | 234161 | Medicine | A | 3/24/2016 | |
| UPTRAVI selexipag 1600 microgram film-coated tablet blister pack | 234164 | Medicine | A | 3/24/2016 | |
| UPTRAVI selexipag 1400 microgram film-coated tablet blister pack | 234165 | Medicine | A | 3/24/2016 | |
| UPTRAVI selexipag 400 microgram film-coated tablet blister pack | 234160 | Medicine | A | 3/24/2016 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| UPTRAVI | 02451212 | Tablet - Oral | 1400 MCG | 4/21/2016 | |
| UPTRAVI | 02451204 | Tablet - Oral | 1200 MCG | 4/21/2016 | |
| UPTRAVI | 02451182 | Tablet - Oral | 800 MCG | 4/21/2016 | |
| UPTRAVI | 02451166 | Tablet - Oral | 400 MCG | 4/21/2016 | |
| UPTRAVI | 02451190 | Tablet - Oral | 1000 MCG | 4/21/2016 | |
| UPTRAVI | 02451158 | Tablet - Oral | 200 MCG | 4/21/2016 | |
| UPTRAVI | 02451174 | Tablet - Oral | 600 MCG | 4/21/2016 | |
| UPTRAVI | 02451220 | Tablet - Oral | 1600 MCG | 4/21/2016 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| UPTRAVI 1600 MCG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1151083010 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| UPTRAVI 600 MCG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1151083005 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| UPTRAVI 400 MCG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1151083004 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| UPTRAVI 200 MCG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1151083002 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| UPTRAVI 1000 MCG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1151083007 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| UPTRAVI 1200 MCG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1151083008 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| UPTRAVI 1400 MCG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1151083009 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| UPTRAVI 800 MCG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1151083006 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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