Drugs / Hydromorphone
last change 10 days ago re-read 8 days ago

Hydromorphone

Other / unclassified targets OPRM1 via activation

Developed for
chronic pain syndrome · neuropathy, painful · osteoarthritis, knee · cancer · osteoarthritis, hip · acute coronary syndrome · hematopoietic and lymphoid cell neoplasm · heroin dependence
+6 more · mucositis · musculoskeletal system disorder · pregnancy disorder · sickle cell disease · cancer of unknown primary site · migraine disorder
Investigated by
Alza Corporation · Montefiore Medical Center · National Institute on Drug Abuse (NIDA) · Johns Hopkins University · Mallinckrodt · Mayo Clinic
+87 more · Fujian Cancer Hospital · Janssen Korea, Ltd., Korea · M.D. Anderson Cancer Center · Emory University · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Maternal and Child Health Hospital of Hubei Province · Mount Sinai Hospital, Canada · National Cancer Institute (NCI) · Patient-Centered Outcomes Research Institute · Piramal Critical Care, Ltd. · Purdue Pharma LP · Second Hospital of Jilin University · University of Alberta · University of British Columbia · University of Chicago · University of Michigan · Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Albert Einstein College of Medicine · Allina Health System · Archimedes Pharma US, Inc. · Beth Israel Deaconess Medical Center · Brigham and Women's Hospital · Canadian Institutes of Health Research (CIHR) · Cape Fear Valley Health System · Children's Mercy Hospital Kansas City · Columbia University · Duke University · Erasmus Medical Center · First Affiliated Hospital, Sun Yat-Sen University · Grace Shih, MD · Grünenthal GmbH · Gyeongsang National University Hospital · Hamilton Health Sciences Corporation · Hordinsky, Maria K., MD · Icahn School of Medicine at Mount Sinai · Indivior Inc. · Innerchange Charitable Society · Janssen Pharmaceutica · Janssen Pharmaceutica N.V., Belgium · Janssen Research & Development, LLC · Janssen-Cilag International NV · Jinshazhou Hospital of Guangzhou University of Chinese Medicine · Johnson & Johnson Taiwan Ltd · Jun Wang · Liquan Liang · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Masimo Corporation · McMaster University · Mundipharma Research GmbH & Co KG · Nanfang Hospital, Southern Medical University · National Heart, Lung, and Blood Institute (NHLBI) · Northwestern University · Nova Scotia Health Authority · OrthoCarolina Research Institute, Inc. · Parc de Salut Mar · Peking University People's Hospital · Providence Healthcare · Qianfoshan Hospital · Qinghai Red Cross Hospital · Roswell Park Cancer Institute · Second Affiliated Hospital, School of Medicine, Zhejiang University · St. Louis Children's Hospital · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · The Hospital for Sick Children · The Physicians' Services Incorporated Foundation · Thomas Jefferson University · TriHealth Inc. · Universidad Europea de Canarias · University Health Network, Toronto · University of Calgary · University of California, San Francisco · University of Manitoba · University of Maryland, Baltimore · University of Montreal Hospital Centre (CHUM) · all 93 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) DILAUDID-HP — 2009-04-30 fda.gov ↗
Approved US (FDA) DILAUDID-HP — 1984-01-11 fda.gov ↗

Trials 123 · started per year

today
US approved 1984
1
2
1
4
1
5
2
2
1
3
3
6
5
3
4
8
8
4
6
4
4
6
5
7
3
7
5
5
4
3
1
19831984198519861987198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT07489625 Mar 2026 → Dec 2027 expected — Qinghai Red Cross Hospital Not yet recruiting No outcome recorded
Phase 0 NCT05610072 Dec 2022 → Mar 2026 substance-related disorder William Stoops Completed No outcome recorded
Phase 0 NCT01866254 May 2013 → Dec 2017 — Grace Shih, MD Completed No outcome recorded
Phase 112 trials
Phase 1 NCT04081376 Nov → Dec 2019 — Parc de Salut Mar Completed No outcome recorded
Phase 1 NCT03933865 Oct 2018 → Feb 2022 opiate dependence University of California, San Francisco Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT02787928 Apr 2016 → Dec 2017 — Virginia Commonwealth University Terminated No outcome recorded
Phase 1 NCT01642030 Aug 2013 → Jul 2017 opiate dependence Johns Hopkins University Completed No outcome recorded
Phase 1 NCT01824524 Dec 2011 → Aug 2012 — Xian-Janssen Pharmaceutical Ltd. Completed No outcome recorded
Phase 1 NCT01487564 Oct 2011 → Jan 2012 — Janssen Research & Development, LLC Completed No outcome recorded
Phase 1 NCT01487512 Mar → Jul 2011 — Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Completed No outcome recorded
Phase 1 NCT03768024 Jun → Oct 2007 — Grünenthal GmbH Completed No outcome recorded
Phase 1 NCT00853554 Dec 2002 — Mallinckrodt Completed No outcome recorded
Phase 1 NCT00399295 ? → Jun 1997 — Alza Corporation Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT07846020 Jan 2027 → Jan 2032 expected chronic pain syndrome University of Maryland, Baltimore Not yet recruiting No outcome recorded
Phase 1/2 NCT07672301 Mar 2026 → Jun 2027 expected — University of Chicago Recruiting No outcome recorded
Phase 1/2 NCT06949059 Jan 2025 → Dec 2026 expected acute coronary syndrome The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Recruiting No outcome recorded
Phase 1/2 NCT00177060 Oct 2003 → May 2007 — Hordinsky, Maria K., MD Terminated No outcome recorded Stop: Business
Phase 221 trials · 2 missed
Phase 2 NCT07224620 Nov 2025 → May 2026 — Beth Israel Deaconess Medical Center Completed No outcome recorded
Phase 2 NCT06036797 Sep → Oct 2023 — Maternal and Child Health Hospital of Hubei Province Unknown No outcome recorded
Phase 2 NCT05579223 Oct 2022 → Jan 2024 anus disorder Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Completed No outcome recorded
Phase 2 NCT05901441 Jun 2022 → May 2023 — Maternal and Child Health Hospital of Hubei Province Completed No outcome recorded
Phase 2 NCT05565495 Jan 2022 → Sep 2024 overdue — Xiaobo Yang, MD Recruiting No outcome recorded
Phase 2 NCT04243954 Apr → Oct 2020 — Fujian Cancer Hospital Completed No outcome recorded
Phase 2 NCT04036968 Feb 2020 → Nov 2022 substance-related disorder Johns Hopkins University Completed Mixed
Phase 2 NCT03767933 Apr 2019 → Mar 2023 musculoskeletal system disorder University of Alberta Completed Missed primary
Phase 2 NCT03098563 Nov 2017 → Nov 2023 osteoarthritis, knee Johns Hopkins University Completed No outcome recorded
Phase 2 NCT02901275 Dec 2016 → Mar 2020 — Johns Hopkins University Completed Mixed
Phase 2/32 trials
Phase 2/3 NCT00992576 Jan 2010 → Nov 2011 constipation disorder Mundipharma Research GmbH & Co KG Completed No outcome recorded
Phase 2/3 NCT00305058 Jul 2005 → Mar 2007 — Montefiore Medical Center Completed No outcome recorded
Phase 333 trials · 2 met primary · 2 missed
Phase 3 NCT04785768 Jul 2021 → May 2024 — Fujian Cancer Hospital Completed No outcome recorded
Phase 3 NCT03933397 Aug 2019 → May 2022 sickle cell disease Duke University Terminated Missed primary Stop: Enrollment
Phase 3 NCT03375515 Sep 2018 → Dec 2019 — Fujian Cancer Hospital Completed No outcome recorded
Phase 3 NCT05576675 May 2018 → Mar 2022 — Xijing Hospital Completed No outcome recorded
Phase 3 NCT03214510 Oct 2017 → Jul 2027 expected hepatobiliary disorder M.D. Anderson Cancer Center Active not recruiting No outcome recorded
Phase 3 NCT02321319 Mar 2017 → Feb 2019 chronic pain syndrome Mallinckrodt Terminated No outcome recorded Stop: Business
Phase 3 NCT02423876 Mar 2015 → Jan 2022 female reproductive organ cancer University of Wisconsin, Madison Completed No outcome recorded
Phase 3 NCT02084355 Apr 2014 → Dec 2015 cancer Gyeongsang National University Hospital Unknown No outcome recorded
Phase 3 NCT01709747 Jun 2013 → Feb 2018 chronic pain syndrome Piramal Critical Care, Ltd. Completed No outcome recorded
Phase 3 NCT01709721 Feb 2013 → Feb 2018 chronic pain syndrome Piramal Critical Care, Ltd. Completed No outcome recorded
Phase 431 trials · 3 met primary · 1 missed
Phase 4 NCT06784180 Feb 2026 → Jan 2029 opiate dependence University of North Carolina, Chapel Hill Withdrawn No outcome recorded Stop: Enrollment
Phase 4 NCT06823180 Mar → Aug 2025 — Liquan Liang Completed No outcome recorded
Phase 4 NCT06671002 Jan 2025 → Oct 2026 expected — University of Michigan Recruiting No outcome recorded
Phase 4 NCT06669650 Sep 2024 → Dec 2025 overdue opiate dependence University of Tennessee Graduate School of Medicine Active not recruiting No outcome recorded
Phase 4 NCT06525740 Sep 2024 → Sep 2029 expected female reproductive organ cancer Mayo Clinic Recruiting No outcome recorded
Phase 4 NCT06495632 Aug 2024 → Jul 2026 overdue — Cape Fear Valley Health System Recruiting No outcome recorded
Phase 4 NCT07315022 Aug 2024 → Aug 2025 — First Affiliated Hospital, Sun Yat-Sen University Completed No outcome recorded
Phase 4 NCT05848635 May 2023 → May 2024 pulmonary coin lesion Qianfoshan Hospital Unknown No outcome recorded
Phase 4 NCT05708521 Apr 2023 → May 2024 overdue neuropathy, painful, substance-related disorder Nova Scotia Health Authority Active not recruiting No outcome recorded
Phase 4 NCT05552443 Mar 2023 → Oct 2024 — Mayo Clinic Terminated No outcome recorded
Phase not applicable17 trials · 1 met primary
— NCT06240390 May → Aug 2024 neuropathy, painful Universidad Europea de Canarias Withdrawn No outcome recorded Stop: Enrollment
— NCT06218160 Nov 2022 → Nov 2023 — Second Hospital of Jilin University Completed No outcome recorded
— NCT06205199 Oct 2022 → Nov 2023 — Second Hospital of Jilin University Completed No outcome recorded
— NCT05375916 May 2022 → Nov 2023 substance-related disorder University of Alberta Completed No outcome recorded
— NCT04566250 Feb 2021 → Apr 2022 — McMaster University Completed Met primary
— NCT04044820 Mar 2019 → Dec 2026 expected substance-related disorder University Health Network, Toronto Recruiting No outcome recorded
— NCT04176783 Mar 2018 → Jul 2021 — OrthoCarolina Research Institute, Inc. Completed No outcome recorded
— NCT03478423 Feb 2018 → Sep 2019 — Mount Sinai Hospital, Canada Terminated No outcome recorded Stop: Enrollment
— NCT02880800 Aug 2016 → Aug 2017 neuropathy, painful Mount Sinai Hospital, Canada Unknown No outcome recorded
— NCT02789969 Apr 2016 → Mar 2017 — St. Louis Children's Hospital Unknown No outcome recorded
Comparator or background therapy120 trials
Phase 0 NCT06617949 Comparator Jan 2025 → Dec 2027 expected substance-related disorder Medical College of Wisconsin Recruiting No outcome recorded
Phase 0 NCT04230681 Comparator Feb 2020 → Apr 2022 obstructive sleep apnea syndrome, tonsillitis Washington University School of Medicine Completed No outcome recorded
Phase 0 NCT03579446 Background Nov 2018 → Jun 2023 hematopoietic and lymphoid cell neoplasm, metastatic malignant neoplasm M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 0 NCT03088306 Comparator Jul 2017 → May 2018 lumbar disk degenerative disorder, lumbar spinal stenosis Johns Hopkins University Completed No outcome recorded
Phase 1 NCT06406400 Background May → Jul 2024 opiate dependence AstraZeneca Terminated No outcome recorded
Show all 120 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2016-12-14 Acura Pharmaceuticals Inc. Results Acura Pharmaceutical Provides Development Update on its LIMITx(TM) Technology acurapharm.com ↗
In Study AP-LTX-400 (Study 400), the LTX-04 tablets delivered approximately 50% of the maximum drug concentration in the blood stream (Cmax) following intended 1 and 2 tablet doses compared to DILAUDID.
2016-06-08 Acura Pharmaceuticals Inc. Results Acura Pharmaceutical's LIMITX(TM) Technology Successfully Confirms Oral Abuse Deterrence Capabilities acurapharm.com ↗
LTX-04P tablets, a hydromorphone hydrochloride immediate-release tablet using the Company's new LIMITX oral abuse deterrent technology, successfully retarded the release of the active opioid ingredient when four, six and eight intact tablets were ingested.
2016-04-13 Acura Pharmaceuticals Inc. Results Acura Pharmaceutical's Limitx(TM) Technology Successfully Demonstrates Oral Abuse Deterrence acurapharm.com ↗
However, the 3 tablet LTX-04P dose achieved an average stomach acid pH of 4.7 post-dose and the Cmax was only 3.8 times as high as the single tablet dose, an estimated 22% reduction in Cmax.
2016-02-01 Acura Pharmaceuticals Inc. Regulatory Acura Pharmaceuticals Provides Development Update on Its LIMITX(TM) Abuse Deterrent Technology acurapharm.com ↗
clinical testing of its lead LIMITX™ oral abuse deterrent drug candidate using the opioid hydromorphone HCl (LTX-04) is allowed to proceed under an Investigational New Drug Application (IND)
2009-12-10 Lannett Company, Inc. Regulatory Lannett Receives FDA Approvals For Hydromorphone Hydrochloride Tablets USPPDF Version investorroom.com ↗
it has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg and 8 mg

Evidence & citations 44 cited values

Every value below carries the sentence it was read from. 251 sources stand behind the page.

FieldValueCited text
Known as hydromorphone “This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid dronabinol (Marinol; oral) to the FDA-approved opioid hydromorphone (Dilaudid;...” NCT02901275 ↗
228

“The ice packs, Tylenol, and Toradol regimen consists of around-the-clock ice packs, around-the-clock oral acetaminophen, around-the-clock intravenous ketorolac, and intravenous...” PMID 31201808 ↗ Jun 2019

“Intraoperative analgesia using short-acting opioids (e.g., fentanyl and/or hydromorphone) administered at induction and throughout surgery according to clinician judgment and...” NCT07565870 ↗

“Standard of Care analgosedation of choice using propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam administered according to the...” NCT06429657 ↗

“The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose.” NCT03972397 ↗

“patients will be placed on a patient controlled analgesic (PCA) pump (hydromorphone: loading dose if needed; 5-6 mcg/kg continuous infusion; 5-6 mcg/kg six minute demand dose).” NCT00413582 ↗

“Participants (N = 21; 57% women; mean age = 63.4 ± 6.4 yr) with knee osteoarthritis received oral combinations of placebo, hydromorphone (2 mg), and dronabinol (10 mg).” PMID 41481837 ↗ Dec 2025

“Total IntraVenous Anesthesia - to achieve deep-sedation via chemical analgesic (propofol, dexmedetomidine, fentanyl, hydromorphone); continuous intravenous infusion.” NCT07672301 ↗

“PACU analgesia for both groups will be the usual care regime of fentanyl or hydromorphone bolus as prescribed by the physician anesthesiologist doing the case.” NCT05693675 ↗

“The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.” NCT03393117 ↗

“Intra-operatively, opioids will be titrated to heart rate and spontaneous respiration rate e.g. fentanyl, morphine, hydromorphone.” NCT03471442 ↗

Show 218 more sources

Known as Dilaudid “This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid dronabinol (Marinol; oral) to the FDA-approved opioid hydromorphone (Dilaudid;...” NCT02901275 ↗
18

“The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose.” NCT03972397 ↗

“Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with or without the preceded co-injection of Hylenex.” NCT00547664 ↗

“Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.” NCT01447888 ↗

“Patients in both groups will have PCA dilaudid or morphine prescribed for the post-operative period.” NCT03458598 ↗

“Dilaudid SR Tablets and Immediate Release Dilaudid Tablets (Hydromorphone HCI)” NCT00410943 ↗

“If intolerant to Oxycodone: second agent line is Hydrocodone or Oral Dilaudid” NCT02219581 ↗

“Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.” NCT03052816 ↗

“injectable hydromorphone (HDM; trade name Dilaudid™)” NCT01447212 ↗

“FDA-approved opioid hydromorphone (Dilaudid; oral)” NCT04036968 ↗

“The PCA drug will be Dilaudid (hydromorphone).” NCT02111746 ↗

Show 8 more sources

Known as Dilaudid CR “An Effectiveness, Safety and Quality of Life Measures With Hydromorphone HCL, Dilaudid CR (Controlled Release)” NCT00399048 ↗
1

“Dilaudid CR (Hydromorphone HCI)” NCT00411268 ↗

Known as Dilaudid CR (controlled release) “A Study on Efficacy (Effectiveness), Safety, and Impact on Quality of Life Measures of Dilaudid CR (Controlled Release);, Hydromorphone HCl in Patients With Chronic Low Back Pain” NCT00398788 ↗
Known as Dilaudid OROS “Dilaudid OROS 16mg (Dilaudid Slow Release; hydromorphone HCL)” NCT00399295 ↗
Known as Dilaudid Slow Release “Dilaudid OROS 16mg (Dilaudid Slow Release; hydromorphone HCL)” NCT00399295 ↗
Known as Dilaudid SR “A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR( Hydromorphone HCI) in Patients With Chronic Cancer Pain” NCT00411034 ↗
1

“Safety and Tolerability of Long-Term Administration of Dilaudid SR (Hydromorphone HCI) in Cancer Pain” NCT00410787 ↗

Known as Dilaudid SR Tablets “A Repeated-Dose Pharmacokinetic Evaluation of Dilaudid SR Tablets (Hydromorphone HCI) in Patients With Chronic Pain” NCT00410878 ↗
1

“Dilaudid SR Tablets and Immediate Release Dilaudid Tablets (Hydromorphone HCI)” NCT00410943 ↗

Known as Dilaudid-hp ChEMBL registry synonym — accepted as the source's own label CHEMBL398707 ↗
Known as Dimorphone ChEMBL registry synonym — accepted as the source's own label CHEMBL398707 ↗
Known as Exalgo ChEMBL registry synonym — accepted as the source's own label CHEMBL398707 ↗
Known as HDM “injectable hydromorphone (HDM; trade name Dilaudid™)” NCT01447212 ↗
Known as Hidromorfona ChEMBL registry synonym — accepted as the source's own label CHEMBL398707 ↗
Known as Hydromorph Contin “Group C receives a placebo for extended release hydromorphone Group U receives Hydromorph Contin 3 mg PO BID” NCT03990038 ↗
Known as Hydromorphon ChEMBL registry synonym — accepted as the source's own label CHEMBL398707 ↗
Known as hydromorphone ER “OBJECTIVE: This multicenter, double-blind, placebo-controlled study using a randomized withdrawal design evaluated the efficacy and safety of once-daily OROS hydromorphone ER...” PMID 20429852 ↗ Jun 2010
Known as Hydromorphone HCI “A Randomized, Repeated- Dose, Parallel-Group Comparison of Safety, Efficacy, and Quality of Life Measures With Dilaudid CR (Hydromorphone HCI) or Oxycontin (Oxycodone HCI) in...” NCT00399048 ↗
3

“OROS Hydromorphone HCI (slow release)” NCT00411034 ↗

“appropriate dose of hydromorphone HCI” NCT00410943 ↗

“OROS Hydromorphone HCI (slow release)” NCT00410878 ↗

Known as Hydromorphone HCL “A Study on Efficacy (Effectiveness), Safety, and Impact on Quality of Life Measures of Dilaudid CR (Controlled Release);, Hydromorphone HCl in Patients With Chronic Low Back Pain” NCT00398788 ↗
3

“Hydromorphone Hcl 4 milligram (mg) Tab 2 times after surgery as basic medication.” NCT03541759 ↗

“Hydromorphone HCl OROS 8 milligram (mg) once daily for 2 weeks.” NCT01006356 ↗

“Dilaudid OROS 16mg (Dilaudid Slow Release; hydromorphone HCL)” NCT00399295 ↗

Known as hydromorphone hydrochloride “Drug: Hydromorphone Hydrochloride Hydromorphone hydrochloride injection is used for perioperative lung tumor ablation” NCT05848635 ↗
6

“Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)” NCT01006356 ↗

“hydromorphone hydrochloride 4 milligrams” NCT03757559 ↗

NCT01709721 ↗

NCT03128346 ↗

NCT03214510 ↗

NCT02604589 ↗

Known as Hydromorphone hydrochloride cii ChEMBL registry synonym — accepted as the source's own label CHEMBL398707 ↗
Known as Hydromorphone Hydrochloride Injection “Experimental Drug: Hydromorphone Hydrochloride Injection.” NCT05579223 ↗
Known as HYDROMORPHONE SULFATE ChEMBL registry synonym — accepted as the source's own label CHEMBL398707 ↗
Known as IDS-NH-004 ChEMBL registry synonym — accepted as the source's own label CHEMBL398707 ↗
Known as IVH “OBJECTIVE: Intranasal fentanyl (INF) quickly and noninvasively relieves severe pain, whereas intravenous hydromorphone (IVH) reliably treats severe cancer pain but requires...” PMID 32649717 ↗ Jul 2020
Known as Jurnista ChEMBL registry synonym — accepted as the source's own label CHEMBL398707 ↗