Last reviewed 2026-05-23 · How we verify

Rhenium-188-HEDP

Amsterdam UMC, location VUmc · Phase 3 active Small molecule ✓ Verified May 2026

Rhenium-188-HEDP is a Radiopharmaceutical Small molecule drug developed by Amsterdam UMC, location VUmc. It is currently in Phase 3 development for Metastatic bone pain from osteoblastic bone lesions, Bone metastases in cancer patients. Also known as: Re-188-HEDP, 188Rhenium-etidronate.

Rhenium-188-HEDP is a radiopharmaceutical that localizes to areas of increased bone metabolism and delivers beta radiation directly to bone lesions for pain palliation and potential therapeutic benefit.

Rhenium-188-HEDP is a small molecule used in the treatment of prostate cancer metastatic to bone. It is being studied in clinical trials, including NCT03458559, as a potential treatment option for patients with advanced prostate cancer refractory to hormonal therapy.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Rhenium-188-HEDP
Also known as	Re-188-HEDP, 188Rhenium-etidronate
Sponsor	Amsterdam UMC, location VUmc
Drug class	Radiopharmaceutical
Target	Bone hydroxyapatite (via HEDP bisphosphonate moiety)
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Rhenium-188 is a beta-emitting radionuclide complexed with HEDP (1,1-hydroxyethylidene diphosphonate), a bone-seeking bisphosphonate analog. The complex accumulates in osteoblastic bone lesions with high metabolic activity, delivering localized radiation therapy to metastatic bone disease. This approach combines the targeting specificity of bone-seeking agents with the therapeutic effects of beta radiation.

Approved indications

Metastatic bone pain from osteoblastic bone lesions
Bone metastases in cancer patients

Common side effects

Bone marrow suppression
Transient increase in bone pain (flare)
Hematologic toxicity

Key clinical trials

Rhenium-188-HEDP vs. Radium-223-chloride in Patients With Advanced Prostate Cancer Refractory to Hormonal Therapy (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Rhenium-188-HEDP CI brief — competitive landscape report
Rhenium-188-HEDP updates RSS · CI watch RSS
Amsterdam UMC, location VUmc portfolio CI

Frequently asked questions about Rhenium-188-HEDP

What is Rhenium-188-HEDP?

Rhenium-188-HEDP is a Radiopharmaceutical drug developed by Amsterdam UMC, location VUmc, indicated for Metastatic bone pain from osteoblastic bone lesions, Bone metastases in cancer patients.

How does Rhenium-188-HEDP work?

What is Rhenium-188-HEDP used for?

Rhenium-188-HEDP is indicated for Metastatic bone pain from osteoblastic bone lesions, Bone metastases in cancer patients.

Who makes Rhenium-188-HEDP?

Rhenium-188-HEDP is developed by Amsterdam UMC, location VUmc (see full Amsterdam UMC, location VUmc pipeline at /company/amsterdam-umc-location-vumc).

Is Rhenium-188-HEDP also known as anything else?

Rhenium-188-HEDP is also known as Re-188-HEDP, 188Rhenium-etidronate.

What drug class is Rhenium-188-HEDP in?

Rhenium-188-HEDP belongs to the Radiopharmaceutical class. See all Radiopharmaceutical drugs at /class/radiopharmaceutical.

What development phase is Rhenium-188-HEDP in?

Rhenium-188-HEDP is in Phase 3.

What are the side effects of Rhenium-188-HEDP?

Common side effects of Rhenium-188-HEDP include Bone marrow suppression, Transient increase in bone pain (flare), Hematologic toxicity.

What does Rhenium-188-HEDP target?

Rhenium-188-HEDP targets Bone hydroxyapatite (via HEDP bisphosphonate moiety) and is a Radiopharmaceutical.

Drug class: All Radiopharmaceutical drugs
Target: All drugs targeting Bone hydroxyapatite (via HEDP bisphosphonate moiety)
Manufacturer: Amsterdam UMC, location VUmc — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Metastatic bone pain from osteoblastic bone lesions
Indication: Drugs for Bone metastases in cancer patients
Also known as: Re-188-HEDP, 188Rhenium-etidronate

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing