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Preeclampsia with a systolic blood pressure of 160 mmHg or higher, or a diastolic blood pressure of 110 mmHg or higher on two occasions at least 4 hours apart while on bedrest. It is associated with thrombocytopenia (platelets less than 100,000 per microliter), impaired liver function (twice normal elevation of hepatic transaminases; severe, persistent right upper quadrant or epigastric pain), progressive renal insufficiency (serum creatinine greater than 1.1 mg/dL or doubling of baseline in the absence of other renal disease), pulmonary edema, or new-onset cerebral or visual disturbances.
Biomarker and diagnostic research for severe pre-eclampsia has been reported in the published literature.
No approved treatments are currently available for severe pre-eclampsia. An additional 4 compounds hold orphan drug designation.
While no drugs are FDA-approved specifically for severe pre-eclampsia, some of the following designated compounds may be used off-label in clinical practice. Treatment decisions should be made in consultation with a specialist familiar with this condition.
The following drugs have received orphan drug designation from the FDA for severe pre-eclampsia. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor |
|---|
11 clinical trials registered, 2 recruiting. Interventions under study include drug therapy and other interventions. Pipeline includes 2 PHASE4, 1 PHASE3, 2 PHASE1. Research is sponsored by a mix of industry and academic institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT07261956](https://clinicaltrials.gov/study/NCT07261956) |
Data assembled from 4 of 12 sources · Last updated Sep 18, 2026, 1:51 AM UTC
Designated
Exclusivity End |
|---|
Designation Status |
|---|
Recombinant human placental growth factor | Recombinant human placental growth factor | Aggamin, LLC | 2017 | — | Designated |
allogeneic ex-vivo expanded placental adherent stromal cells | allogeneic ex-vivo expanded placental adherent stromal cells | Pluri Biotech Ltd. | 2015 | — | Designated |
S-nitrosoglutathione | S-nitrosoglutathione | Salupont Consulting Ltd | 2012 | — | Designated |
digoxin immune fab (ovine) | digoxin immune fab (ovine) | AMAG Pharmaceuticals, Inc. | 2012 | — | Designated |
11 trials found
Lung Ultrasound for the Detection of Volume Overload in Patients With Severe Preeclampsia
NA |
Saint Thomas Hospital, Panama |
RECRUITING |
[NCT07361679](https://clinicaltrials.gov/study/NCT07361679) | LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention | PHASE4 | Alexandra Hospital, Athens, Greece | RECRUITING |
211 publications have been identified in PubMed for severe pre-eclampsia. Research spans Epidemiology / Natural History (36%), Clinical Trial Publication (21%), and Case Report / Case Series (19%).
Research Type | Count | % of Total |
|---|---|---|
Disease patterns and progression | 77 | 36% |
Clinical study results | 45 | 21% |
Patient case studies | 41 | 19% |
Testing and diagnosis research | 18 | 9% |
Research summaries | 14 | 7% |
Laboratory research | 14 | 7% |
Other research | 2 | 1% |
Oztürk Ö (2026). [PMID: 41909303](https://pubmed.ncbi.nlm.nih.gov/41909303/). *Cureus*. [Case Report / Case Series]
D'Alberti E (2026). [PMID: 41492769](https://pubmed.ncbi.nlm.nih.gov/41492769/). *Clin Obstet Gynecol*. [Review / Meta-Analysis]
Han-Idhikul A (2026). [PMID: 41789025](https://pubmed.ncbi.nlm.nih.gov/41789025/). *J Pregnancy*. [Epidemiology / Natural History]
Chen Y (2026). [PMID: 40923159](https://pubmed.ncbi.nlm.nih.gov/40923159/). *International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics*. [Epidemiology / Natural History]
Aisagbonhi O (2026). [PMID: 41636024](https://pubmed.ncbi.nlm.nih.gov/41636024/). *Hypertension*. [Epidemiology / Natural History]
da-Costa-Santos J (2026). [PMID: 40781874](https://pubmed.ncbi.nlm.nih.gov/40781874/). *International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics*. [Basic Science / Preclinical]
Ayyash M (2026). [PMID: 41121451](https://pubmed.ncbi.nlm.nih.gov/41121451/). *BJOG*. [Epidemiology / Natural History]
Meher S (2026). [PMID: 41845444](https://pubmed.ncbi.nlm.nih.gov/41845444/). *Trials*. [Clinical Trial Publication]
Ogamba-Alphonso I (2026). [PMID: 41061763](https://pubmed.ncbi.nlm.nih.gov/41061763/). *Am J Perinatol*. [Basic Science / Preclinical]
Wang J (2026). [PMID: 41846880](https://pubmed.ncbi.nlm.nih.gov/41846880/). *Front Med (Lausanne)*. [Clinical Trial Publication]